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Statutory Instruments

2002 No. 618

CONSUMER PROTECTION

The Medical Devices Regulations 2002cross-notes

Made

20th May 2002

Laid before Parliament

21st May 2002

Coming into force

13th June 2002

M1,M2,M3,M4 The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to measures relating to medical devices, in exercise of the powers conferred by the said section 2(2), in exercise, with the consent of the Treasury, of the powers conferred by section 56(1) and (2) of the Finance Act 1973, in exercise of the powers conferred by sections 11 and 27(2) of the Consumer Protection Act 1987, and in exercise of all other powers enabling him in that behalf, after consultation in accordance with section 11(5) of the Consumer Protection Act 1987 with organisations appearing to him to be representative of interests substantially affected by these Regulations, with such other persons considered by him appropriate and with the Health and Safety Commission, hereby makes the following Regulations:—

PART I Introductory Provisions Relating to all Medical Devices

Citation and commencement

1. These Regulations may be cited as the Medical Devices Regulations 2002 and shall come into force 13th June 2002.

Expiry of certain provisions in these Regulations

[F1 1ZA.—(1) Subject to paragraph (3), regulations 19B and 30A cease to have effect at 23:59 on 30 June 2028.

(2) Subject to paragraph (3), regulations 19C, 44ZA and 44ZB cease to have effect at 23:59 on 30 June 2030.

(3) The following cease to have effect at 23:59 on 30 June 2023—

(a)regulation 19B(4), (5), (8) and (9);

(b)regulation 19C(8) and (9);

(c)regulation 30A(4) to (7);

(d)regulation 44ZA(4) and (5);

(e)regulation 44ZB(4) and (5).F1]

[F2Schedules

1A. Schedules 2 and 2A have effect.F2]

Interpretation E1

F3,F42.—(1) ... In these Regulations ...—

[F62 (1A) In these Regulations, any reference to Annexes 1 to 7 to Directive 90/385, Annexes I to X to Directive 93/42 or Annex I to X to Directive 98/79 is to be construed as a reference to those Annexes [F63 as they applied immediately before IP completion day and as modified by Schedule 2A.F63,F62]]

[F64 (1B) In these Regulations, any reference to Annex 1 to Directive 90/385 or to Annex I to Directive 93/42 is to that Annex read with Regulation (EU) No 207/2012.F64]

(2) In these Regulations, unless the context otherwise requires, a reference—

(a)to a numbered regulation, Part or Schedule is to the regulation or Part of, or the Schedule to, these Regulations bearing that number;

(b)in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; and

(c)in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.

Interpretation E49

F5762.—(1) In these Regulations...—

[F612 (1A) In these Regulations, any reference to Annexes 1 to 7 to Directive 90/385, Annexes I to X to Directive 93/42 or Annex I to X to Directive 98/79 is to be construed as a reference to those Annexes as amended from time to time.F612]

[F613 (1B) In these Regulations, any reference to Annex 1 to Directive 90/385 or to Annex I to Directive 93/42 is to that Annex read with Regulation (EU) No 207/2012.F613]

(2) In these Regulations, unless the context otherwise requires, a reference—

(a)to a numbered regulation, Part or Schedule is to the regulation or Part of, or the Schedule to, these Regulations bearing that number;

(b)in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; and

(c)in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.

[F65Medical devices which are qualifying Northern Ireland goods

2A.—(1)[F66 Subject to paragraph (1A),F66] notwithstanding the effect of regulations 19B, 19C, 30A, 44ZA and 44ZB and the expiry of the period during which those regulations apply by virtue of regulation 1ZA, any medical device—

[F67 (a)which meets the requirements of—

(i)these Regulations as they apply in Northern Ireland;

(ii)Regulation (EU) 2017/745; or

(iii)Regulation (EU) 2017/746; andF67]

(b)which is a qualifying Northern Ireland good,

may be placed on the Great Britain market as if it meets the requirements of these Regulations as they apply in Great Britain.

[F68 (1A) Before 25 July 2024, paragraph (1) only applies to a coronavirus test device that meets the requirements of Regulation (EU) 2017/746 if the device also meets the requirements of—

(a)regulation 34A (approval requirement for coronavirus test devices); or

(b)the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107.F68]

(2) In this regulation,

[F69 (a) F69] “qualifying Northern Ireland good” has the meaning given in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018 ;

[F70 (b) “ Regulation (EU) 2017/745 ” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC , Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC . F70,F65]]

Scope of these Regulations E2

3. These Regulations shall not apply to—

(a)F72medicinal products governed by [F71the Human Medicines Regulations 2012F71] (including medicinal products derived from human blood or human plasma ...);

(b)human blood, human blood products, plasma or blood cells of human origin;

(c)devices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for [F73—

(i)stable derivatives devices,

(ii)active implantable medical devices and accessories to such devices, and

(iii)in vitro diagnostic medical devices and accessories to such devices,F73] ;

(d)transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin [F74, except for F75..., in vitro diagnostic medical devices and accessories to such devicesF74][F76 save where medicinal products are incorporated as ancillary to the deviceF76] ;

[F77 (e)transplants or tissues or cells of animal origin, unless—

(i)a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue, or

(ii)a product is F78... an dfnin vitro diagnostic medical device, or an accessory to such a device;F77]

(f)cosmetic products governed by [F79Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products;F79] or

F80(g). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Scope of these Regulations E50

3. These Regulations shall not apply to—

(a)medicinal products governed by Directive 2001/83 (including medicinal products derived from human blood or human plasma governed by Title X of dfnDirective 2001/83);

(b)human blood, human blood products, plasma or blood cells of human origin;

(c)devices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for [F614—

(i)stable derivatives devices,

(ii)active implantable medical devices and accessories to such devices, and

(iii)in vitro diagnostic medical devices and accessories to such devices,F614] ;

(d)transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin [F615, except for F616..., in vitro diagnostic medical devices and accessories to such devicesF615][F617 save where medicinal products are incorporated as ancillary to the deviceF617] ;

[F618 (e)transplants or tissues or cells of animal origin, unless—

(i)a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue, or

(ii)a product is F619... an dfnin vitro diagnostic medical device, or an accessory to such a device;F618]

(f)F620,F621cosmetic products governed by Council Directive 76/768/EEC , as amended ; or

F622(g). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F81Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 [F82and Regulation (EU) 2017/746F82]

3ZA.—(1) Subject to paragraph (2), Parts 2 to 7 only apply in Northern Ireland for the purpose of regulating qualifying devices.F83]

(2) The following provisions continue to apply in Northern Ireland in accordance with this paragraph F84...—

[F85 (a)for the purposes of the registration of medical devices (whether or not they are qualifying devices) and persons placing medical devices on the market in Northern Ireland—

(i)regulation 19 (registration of persons placing general medical devices on the market),

(ii)regulation 21B (registration of persons placing active implantable medical devices on the market),

(iii)regulation 44 (registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation), and

(iv)regulation 53 (fees in connection with the registration of devices and changes to registration details),

only apply until the date which is 24 months after the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745;

(aa)regulations 34A to 34D, 38A to 38C, 39A, 56A, 59 and 61 continue to apply in relation to coronavirus test devices whether or not they are qualifying devices;F85]

(b)Parts 5 to 7 [F86 alsoF86] apply for purposes related to the designation of conformity assessment bodies for the purposes of a UK mutual recognition agreement.

(3)[F87 For the purposes of this regulationF87] , a device is a qualifying device if, by virtue of Article 120 of Regulation (EU) 2017/745 [F88 or Article 110 of Regulation (EU) 2017/746F88] —

(a)it may be placed on the market, put into service or made available in Northern Ireland in accordance with the requirements of [F89 Directive 90/385, Directive 93/42 or Directive 98/79, rather than Regulation (EU) 2017/745 or Regulation (EU) 2017/746; andF89]

(b)it is placed on the market, put into service or made available in Northern Ireland in accordance with, and subject to the requirements of and the arrangements set out in, Parts 2 F90... to 7.F81]

[F91Designated standard

3A. —(1) In Parts II, III and IV of these Regulations, a “ designated standard ” means—

(a)a technical specification which is—

(i)adopted by a recognised standardisation body [F92 or an international standardising bodyF92] , for repeated or continuous application with which compliance is not compulsory; and

(ii)designated by the Secretary of State by publishing a reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate; or

(b)a monograph of the European Pharmacopoeia (in particular on surgical sutures and on the interaction between medicinal products and materials used in devices containing medicinal products) which has been published in the Official Journal of the European Union.

(2) For the purposes of paragraph (1), a “ technical specification ” means a document which prescribes technical requirements to be fulfilled by a device, process, service or system (“the product”) and which lays down—

(a)the characteristics required of a product, including levels of quality, performance, interoperability, environmental protection, health and safety and dimensions;

(b)the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(c)the production methods and processes relating to the product, where these have an effect on its characteristics.

(3) For the purposes of this regulation a “ recognised standardisation body ” means any one of the following organisations—

(a)the European Committee for Standardisation (CEN);

(b)the European Committee for Electrotechnical Standardisation (CENELEC);

(c)the British Standards Institute (BSI).

[F93 (3A) In this regulation “ international standardising body ” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time). F93]

(4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5) Before publishing the reference to a standard in relation to a technical specification which has been adopted by BSI, the Secretary of State must have regard to whether the technical specification is consistent with [F94 suchF94] technical specifications adopted by the other recognised standardisation bodies [F95 or by international standardising bodies as the Secretary of State considers to be relevant.F95]

(6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) In this regulation—

(a) a reference to a “ device ” is a reference to a medical device or its accessory or an in vitro diagnostic medical device or its accessory to which these Regulations apply;

(b) a reference to “ the European Pharmacopoeia ” is a reference to the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia.

Confidentiality

F963B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F91]

Transitional provisions

M54.—(1) Part II shall not be applied before 1st July 2004 in respect of a device which has been subjected to EEC pattern approval before 1st January 1995 in accordance with the Clinical Thermometers (EEC Requirements) Regulations 1993 .

(2) Part II shall not be applied—

(a)before 10th January 2007 in respect of a stable derivatives device placed on the market without a CE marking, if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 10th January 2002; or

(b)before 10th January 2009 in respect of a stable derivatives device put into service without a CE marking, if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 10th January 2002.

(3) Part IV shall not be applied before 7th December 2003 in respect of a device placed on the market which is—

(a)anin vitro diagnostic medical device without a CE marking; or

(b)a device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,

if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 7th December 1998.

(4) Part IV shall not be applied before 7th December 2005 in respect of a device put into service which is—

(a)anin vitro diagnostic medical device without a CE marking; or

(b)a device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,

if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is put into service as in force on 7th December 1998.

[F97 (5) Regulation 13(4) shall not be applied before 1st March 2004 in respect of breast implants which—

(a)bore a CE marking before 1st September 2003; and

(b)satisfy the requirements in respect of relevant devices falling within Class IIb set out in regulation 13(3).F97]

[F98 (6) Regulation 19A shall not be applied before 1st October 2004 in respect of a device placed on the market before 1st April 2004.F98]

[F99Transitional provisions for hip, knee and shoulder replacements

4A.—(1) This regulation applies to hip, knee or shoulder replacements.

(2) Regulation 13(4) shall not apply in respect of a replacement—

(a)whose manufacturer or his authorised representative has before 1st September 2007—

(i)fulfilled the applicable obligations imposed by Annex II, excluding Section 4 of that Annex,

(ii)declared, in accordance with a declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it, and

(iii)ensured that the device meets the provisions of Directive 93/42 which apply to it; and

(b)in respect of which an examination under Section 4 of Annex II has been carried out and an EC design-examination certificate under that Section has been issued before 1st September 2009.

(3) Regulation 13(4) shall not apply before 1st September 2009 in respect of a replacement—

(a)whose manufacturer or his authorised representative has—

(i)fulfilled the applicable obligations imposed by Annex II, excluding Section 4 of that Annex,

(ii)declared, in accordance with a declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it, and

(iii)ensured that the device meets the provisions of Directive 93/42 which apply to it; and

(b)which is covered by the decision of a notified body issued in accordance with Section 3.3 or 3.4 of Annex II before 1st September 2007.

(4) Regulation 13(4) shall not apply before 1st September 2010 in respect of replacement—

(a)whose manufacturer or his authorised representative has—

(i)fulfilled the applicable obligations imposed by Annex III together with Annex VI,

(ii)declared, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it, and

(iii)ensured that the device meets the provisions of Directive 93/42 which apply to it; and

(b)which is covered by the decision of a notified body issued in accordance with Section 3.3 or 3.4 of Annex VI before 1st September 2007.

(5) Regulation 13(4) shall not apply in respect of a replacement which—

(a)satisfies the conditions set out in paragraph (4)(a) and (b);

(b)has been placed on the market before 1st September 2010; and

(b)is put into service on or after that date.F99]

[F100Revocations, transitional and saving provisions in respect of the new national registration requirements

4D.—(1) Regulation 19 is revoked on the day that is 4 months after IP completion day (which is when regulation 7A comes into force).

(2) Regulation 7A does not apply until the day that is 8 months after IP completion day in respect of a device or accessory—

(a) that is a relevant device for the purposes of Part II; and

(b)that is classified as belonging to—

(i)Class IIa, as referred to in regulation 7, or

(ii)Class IIb, as referred to in regulation 7, and is also a Group A device (within the meaning given in regulation 52(1)).

(3) Regulation 7A does not apply until the day that is 12 months after IP completion day in respect of a device or accessory—

(a) that is a relevant device for the purposes of Part II; and

(b)that is classified as belonging to Class I, as referred to in regulation 7.

(4) Where regulation 7A does not apply in respect of a device or accessory by virtue of paragraph (2) or (3), regulation 19 continues to have effect after its revocation in respect of that device or accessory.

(6) Regulation 30(3) is revoked on the day that is 4 months after IP completion day (which is when regulation 21A comes into force).

(8) Regulation 44 is revoked on the day that is 4 months after IP completion day (which is when regulation 33A comes into force).

(9) Regulation 33A does not apply until the day that is 8 months after IP completion day in respect of a device or accessory—

(a) that is a relevant device for the purposes of Part IV, or

(b)that is—

(i)referred to in List B, mentioned in regulation 40(4), or

(ii)a device for self-testing (as defined in relation 32(1)).

(10) Regulation 33A does not apply until the day that is 12 months after IP completion day in respect of a device or accessory that is a relevant device for the purposes of Part IV which follows the procedure in regulation 40(1).

(11) Where regulation 33A does not apply in respect of a device or accessory by virtue of paragraph (9), regulation 44 continues to have effect after its revocation in respect of that device or accessory.F100]

Revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date

F1014H. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F102Revocation of Commission Decision 2010/227

4I. Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) is revoked.

Revocation of Commission Regulation (EU) No 207/2012 on 26th May 2025

F1034J. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation of Regulation (EU) No 722/2012 on 26th May 2025

F1044K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date

F1054L. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation of Regulation (EU) No 2017/2185 and saving provision

4M.—(1) Insofar as it is retained EU law, Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (“Regulation (EU) No 2017/2185”) is revoked.

The classification criteria in Directives 2003/12 and 2005/50

F1064N. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocation of Regulation (EU) 2017/745

4O.—(1) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (“the Medical Devices Regulation”) (insofar as it is retained EU law) is revoked.

Revocation of Regulation (EU) 2017/746

4P.—(1) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“the in vitro diagnostic medical devices Regulation”) (insofar as it is retained EU law) is revoked.F102]

[F107References in other legislation to Directives 90/385, 93/42 and 98/79

4T.F108—(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) In regulation 10(5) of the Medicines (Products for Human Use) (Fees) Regulations 2016 (fee for advice for other purposes)—

(a) the reference to the expression “medical device” having the meaning given in Article 1(2)(a) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to having the meaning given in regulation 2; and

F109(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F110 (c) the reference to the expression “ Directive 93/42/EEC ” is to be construed, to the extent necessary for the practical application of that expression, as a reference also or instead to Part II of the Medical Devices Regulations 2002 ;

(d) the references to “paragraph 4.3 of Annex II to Directive 93/42/EEC ” and “paragraph 5 of Annex III to Directive 93/42/EEC ” are to be construed, to the extent necessary for the practical application of those provisions, as references also or instead to those paragraphs and those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A. F110]

(3) In Schedule 1 to the Pressure Equipment (Safety) Regulations 2016 (excluded pressure equipment and assemblies), the reference in paragraph 1(f)(iv) to not being covered by Directive 93/42 is to be construed, to the extent necessary for the practical application of that provision, as a reference also or instead to not being covered by Part II.

(4) In regulation 2 of the Waste Electrical and Electronic Equipment Regulations 2013 (interpretation)—

(a) the reference to the expression “active implantable medical device” having the meaning given in Article 1(2)(c) of Directive 90/385 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to it having the meaning given in regulation 2 F111 ...;

(b) the reference to the expression “medical device” having the meaning given in Article 1(2)(a) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference to it also or instead having the meaning given to it in regulation 2;

(c) the reference to the expression “accessory” having the meaning given in Article 1(2)(b) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as also or instead having the meaning given to “accessory” in regulation 5;

(d) the reference to the expression “in vitro diagnostic medical device” having the meaning given in Article 1(2)(b) of Directive 98/79 is to be construed, to the extent necessary for the practical application of that definition, as having the meaning given to it in regulation 2;

(e) the reference to the expression “accessory” having the meaning given in Article 1(2)(c) of Directive 98/79 is to be construed, to the extent necessary for the practical application of that definition, as also or instead having the meaning given to “accessory” in regulation 32.

(5) These Regulations are an enactment implementing a relevant Community Directive for the purposes of regulation 4 of the Personal Protective Equipment at Work Regulations (Northern Ireland) 1993 (provision of personal protective equipment).

(6) These Regulations are also an enactment implementing a relevant Community Directive for the purposes of regulation 4(5)(a) of the Personal Protective Equipment at Work Regulations 1992 (provision of personal protective equipment).F107]

PART II General Medical Devices

Interpretation of Part II

F1125.—(1) In this Part ...—

F112(2) In this Part ..., a reference to a numbered article or Annex is to the article or Annex of Directive 93/42 bearing that number.

Scope of Part II

6. The requirements of this Part in respect of relevant devices apply in respect of medical devices (including stable derivatives devices), accessories to such devices, single-use combination products, and systems and procedure packs, other than—

(a)active implantable medical devices and accessories to such devices; [F114andF114]

(b)in vitro diagnostic medical devices and accessories to such devices; [F115andF115]

(c) [F116 devices that come within the scope of Directive 93/42 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

(i)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

(ii)the manufacturer chooses to follow the set of arrangements in the other Directive.F116]

Classification of general medical devices E3

7.—(1) For the purposes of this Part and Part VI, devices are classified as belonging to Class I, IIa, IIb or III in accordance with the classification criteria set out in Annex IX of Directive 93/42[F117 , read with Directive 2003/12F117][F118 and Directive 2005/50F118] .

(2) In the event of a dispute between a manufacturer and [F119an approved bodyF119] over the classification of a device, the matter shall be referred to the Secretary of State, who shall determine the classification of the device in accordance with the classification criteria set out in Annex IX of Directive 93/42[F117 , read with Directive 2003/12F117][F118 and Directive 2005/50F118] .

Classification of general medical devices E51

7.—(1) For the purposes of this Part and Part VI, devices are classified as belonging to Class I, IIa, IIb or III in accordance with the classification criteria set out in Annex IX of Directive 93/42[F623 , read with Directive 2003/12F623][F624 and Directive 2005/50F624] .

(2) In the event of a dispute between a manufacturer and a notified body over the classification of a device, the matter shall be referred to the Secretary of State, who shall determine the classification of the device in accordance with the classification criteria set out in Annex IX of Directive 93/42[F623 , read with Directive 2003/12F623][F624 and Directive 2005/50F624] .

[F120Registration of persons placing general medical devices on the market

7A.—(1) No person may place a relevant device on the market in accordance with this Part unless that person—

(a)is established in Great Britain; and

(b)has complied with paragraph (2).

(2) A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—

(a)where—

(i)that person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;

(ii)that person is the manufacturer of that device and is based outside the United Kingdom, the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; or

(iii)that person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;

(b)that person supplies the Secretary of State with a description of the relevant device; and

(c)that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

(3) The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—

(a)ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b)keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c)in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d) where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access;

(e)where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;

(f)cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(g)immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;

(h)if the manufacturer acts contrary to its obligations under these Regulations—

(i)terminate the legal relationship with the manufacturer; and

(ii)inform the Secretary of State and, if applicable, the relevant approved body of that termination.

(4) In this regulation—

(a) the references to “technical documentation” are to be construed in accordance with Annex II, III or VII;

(b) the references to “declaration of conformity” are to be construed in accordance with Annexes II, IV, V, VI and VII. F120]

Essential requirements for general medical devices E4

8.—(1) Subject to regulation 12, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it [F121and the requirements set out in Regulation (EU) No 722/2012 (if applicable)F121] .

(2) Subject to regulation 12, no person shall supply a relevant device—

(a)if that supply is also a placing on the market or putting into service of that device; or

(b)in circumstances where that device has been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex I which apply to it [F122and the requirements set out in Regulation (EU) No 722/2012 (if applicable)F122] .

[F123 (3) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in [F124 Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008F124] to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.F123]

Essential requirements for general medical devices E52

8.—(1) Subject to regulation 12, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it [F625and the requirements set out in Regulation (EU) No 722/2012 (if applicable)F625] .

(2) Subject to regulation 12, no person shall supply a relevant device—

(a)if that supply is also a placing on the market or putting into service of that device; or

(b)in circumstances where that device has been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex I which apply to it [F626and the requirements set out in Regulation (EU) No 722/2012 (if applicable)F626] .

[F627 (3) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Annex I to Directive 2006/42 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.F627]

Determining compliance of general medical devices with relevant essential requirements E5

9.—(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

(2) Where confirmation of conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Annex X.

(3) In the case of a relevant device which is being or has been put into service—

(a)the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and

(b)the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if—

(i)F125such instructions are in English ...

F126(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant [F127designated standardF127] , unless there are reasonable grounds for suspecting that it does not comply with that requirement.

(5) A custom-made device—

(a)in respect of which the conditions specified in Annex VIII are satisfied; and

(b)in the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Annex VIII,

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

[F128 (5A) When a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device—

(a)ensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII; and

(b)ensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request.F128]

(6) Where, in accordance with Section 2.1 of Annex VIII, a manufacturer of a custom-made device, or [F129their UK responsible personF129] , has indicated that specified essential requirements have not been fully met, and has given proper grounds as to why they have not been fully met, those specified essential requirements are no longer to be treated as relevant essential requirements for that device.

(7) A device intended for clinical investigation in respect of which—

(a)the conditions specified in Annex VIII are satisfied;

(b)notice has been given under regulation 16(1); and

(c)either—

(i)no notice has been given under regulation 16(4) within the period of 60 days there referred to, or

(ii)notice has been given under regulation 16(5),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

F130(8) A single-use combination product shall be taken to comply with the relevant essential requirements if the medical device which forms part of that product only complies with the requirements set out in Annex I ... that relate to safety and performance, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device, in which case the single-use combination product must comply with all the relevant essential requirements which apply to it.

[F131 (9) Where a device is intended by the manufacturer to be used in conjunction with both the provisions in [F132 Regulation (EU) 2016/425 of the European Parliament and of the Council of 9th March 2016 on personal protective equipment and repealing Council Directive 89/686/EECF132] and Directive 93/42, the relevant basic health and safety requirements of [F133 Regulation (EU) 2016/425F133] shall also be fulfilled.F131]

Determining compliance of general medical devices with relevant essential requirements E53

9.—(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

(2) Where confirmation of conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Annex X.

(3) In the case of a relevant device which is being or has been put into service—

(a)the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and

(b)the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if—

(i)such instructions are in English or another Community language, and

(ii)if the instructions are not in English, any packaging, label or promotional literature carries a clear statement in English stating the language in which the instructions are given.

(4) A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant national standard, unless there are reasonable grounds for suspecting that it does not comply with that requirement.

(5) A custom-made device—

(a)in respect of which the conditions specified in Annex VIII are satisfied; and

(b)in the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Annex VIII,

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

[F628 (5A) When a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device—

(a)ensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII; and

(b)ensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request.F628]

(6) Where, in accordance with Section 2.1 of Annex VIII, a manufacturer of a custom-made device, or his authorised representative, has indicated that specified essential requirements have not been fully met, and has given proper grounds as to why they have not been fully met, those specified essential requirements are no longer to be treated as relevant essential requirements for that device.

(7) A device intended for clinical investigation in respect of which—

(a)the conditions specified in Annex VIII are satisfied;

(b)notice has been given under regulation 16(1); and

(c)either—

(i)no notice has been given under regulation 16(4) within the period of 60 days there referred to, or

(ii)notice has been given under regulation 16(5),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

(8) A single-use combination product shall be taken to comply with the relevant essential requirements if the medical device which forms part of that product only complies with the requirements set out in Annex I of Directive 93/42 that relate to safety and performance, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device, in which case the single-use combination product must comply with all the relevant essential requirements which apply to it.

[F629 (9) Where a device is intended by the manufacturer to be used in conjunction with both the provisions in Council Directive 89/686/EEC on the approximation or the laws of the Member States relating to personal protective equipment and Directive 93/42, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.F629]

[F134UK markingF134] of general medical devices E6

10.—(1) Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device or its sterile pack bears a [F135UK markingF135] which—

(a)meets the requirements set out in [F136Annex 2 of Regulation ;(EC) No 765/2008F136]

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant [F137approved bodyF137] or conformity assessment body identification number for that device.

(2) Subject to regulations 12 and 14, no person shall supply a relevant device unless, where practical and appropriate, that device or its sterile pack bears a [F138UK markingF138] which—

(a)meets the requirements set out in [F139Annex 2 of Regulation ;(EC) No 765/2008F139]

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant [F140approved bodyF140] or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.

(3) Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless [F141a UK marking meeting the requirements of Annex 2 of Regulation , appears on— (EC) No 765/2008F141]

(a)any sales packaging for that device; and

(b)the instructions for use for the device,

and that [F142UK markingF142] is accompanied by any relevant [F143approved bodyF143] or conformity assessment body identification number for that device.

(4) Subject to regulations 12 and 14, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless [F144a UK marking meeting the requirements of Annex 2 of Regulation , appears on— (EC) No 765/2008F144]

(a)any sales packaging for that device; and

(b)the instructions for use for the device,

and that [F145UK markingF145] is accompanied by any relevant [F146approved bodyF146] or conformity assessment body identification number for that device.

(5) No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a)a relevant device or its sterile pack;

(b)the instructions for use for a relevant device; or

(c)any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the [F147UK markingF147] or which reduces the visibility or the legibility of the [F147UK markingF147] .

[F148 (6) In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—

(a)as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and

(b)as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).F148]

CE marking of general medical devices E54

10.—(1) Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device or its sterile pack bears a CE marking which—

(a)meets the requirements set out in Annex XII;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(2) Subject to regulations 12 and 14, no person shall supply a relevant device unless, where practical and appropriate, that device or its sterile pack bears a CE marking which—

(a)meets the requirements set out in Annex XII;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.

(3) Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless a CE marking, meeting the requirements set out in Annex XII, appears on—

(a)any sales packaging for that device; and

(b)the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(4) Subject to regulations 12 and 14, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a CE marking, meeting the requirements set out in Annex XII, appears on—

(a)any sales packaging for that device; and

(b)the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(5) No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a)a relevant device or its sterile pack;

(b)the instructions for use for a relevant device; or

(c)any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the CE marking or which reduces the visibility or the legibility of the CE marking.

[F149UK(NI) indication: general medical devices

10A.—(1) Where the CE marking referred to in regulation 10 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a)visibly, legibly and indelibly; and

(b)before a relevant device is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever such marking is affixed in accordance with regulation 13.

[F150 (3A) The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.F150]

(4) The UK(NI) indication must be affixed by the manufacturer.

(5) Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.

(6) No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service.F149]

[F151 UK marking of general medical devices that come within the scope of this Part and other legislation E7

11. Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied. F151]

CE marking of general medical devices that come within the scope of more than one Directive E55

11. Where a relevant device comes within the scope of Directive 93/42 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, no person shall affix a CE marking to the device unless the relevant requirements of the other Directive are also satisfied, except where—

(a)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it;

(b)the manufacturer chooses to follow the set of arrangements in Directive 93/42;

(c)the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and

(d)the particulars of Directive 93/42, as published in the Official Journal of the [F630European UnionF630] , are given in the documents, notices or instructions accompanying the device.

Exemptions from regulations 8 and 10 E8

F15212.—(1) A relevant device or a single use combination product being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of ... these Regulations.

(2) Regulation 10 shall not apply to a custom-made device or a device intended for clinical investigation.

(3) Regulation 10 shall not apply to a relevant device which is a system or procedure pack, unless—

(a)the system or procedure pack incorporates a medical device which does not bear a [F153UK markingF153] ; or

(b)the chosen combination of medical devices is not compatible in view of their original intended use.

(4) Regulation 10 shall not apply to single-use combination products, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device which forms part of that product.

(5) Regulations 8 and 10 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a [F154UK markingF154] , where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

[F155 (6) Regulations 8 and 10 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards, or which is marked other than with a UK marking, which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 8 and 10, may be placed on the market.

( 7) In paragraph (6), the Secretary of State, in determining whether another standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 8 and 10, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations. F155]

Exemptions from regulations 8 and 10 E56

12.—(1) A relevant device or a single use combination product being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of Directive 93/42 or these Regulations.

(2) Regulation 10 shall not apply to a custom-made device or a device intended for clinical investigation.

(3) Regulation 10 shall not apply to a relevant device which is a system or procedure pack, unless—

(a)the system or procedure pack incorporates a medical device which does not bear a CE marking; or

(b)the chosen combination of medical devices is not compatible in view of their original intended use.

(4) Regulation 10 shall not apply to single-use combination products, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device which forms part of that product.

(5) Regulations 8 and 10 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

Procedures for affixing a [F156UK markingF156] to general medical devices E9

13.—(1) A relevant device falling within Class I may bear a [F157UK markingF157] only if its manufacturer or [F158their UK responsible personF158] —

(a)fulfils the applicable obligations imposed by Annex VII;

(b)declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of [F159this PartF159] which apply to it; and

(c)ensures that the device meets the provisions of [F159this PartF159] which apply to it.

(2) A relevant device falling within Class IIa may bear a [F157UK markingF157] only if its manufacturer or [F158their UK responsible personF158] —

(a)fulfils the applicable obligations imposed by—

(i)Annex II, excluding Section 4 of that Annex, or

(ii)Annex VII, together with Annex IV, V or VI;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F159this PartF159] which apply to it; and

(c)ensures that the device meets the provisions of [F159this PartF159] which apply to it.

(3) A relevant device falling within Class IIb may bear a [F157UK markingF157] only if its manufacturer or [F158their UK responsible personF158] —

(a)fulfils the applicable obligations imposed by—

(i)Annex II, excluding Section 4 of that Annex, or

(ii)Annex III, together with Annex IV, V or VI;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F159this PartF159] which apply to it; and

(c)ensures that the device meets the provisions of [F159this PartF159] which apply to it.

(4) A relevant device falling within Class III may bear a [F157UK markingF157] only if its manufacturer or [F158their UK responsible personF158] —

(a)fulfils the applicable obligations imposed by—

(i)Annex II, or

(ii)Annex III, together with Annex IV or V;

(b)F160declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F159this PartF159] which apply to it; ...

(c)ensures that the device meets the provisions of [F159this PartF159] which apply to it; [F161andF161]

[F162 (d)fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).F162]

F163(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F163(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedures for affixing a CE marking to general medical devices E57

13.—(1) A relevant device falling within Class I may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by Annex VII;

(b)declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it; and

(c)ensures that the device meets the provisions of Directive 93/42 which apply to it.

(2) A relevant device falling within Class IIa may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Annex II, excluding Section 4 of that Annex, or

(ii)Annex VII, together with Annex IV, V or VI;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it; and

(c)ensures that the device meets the provisions of Directive 93/42 which apply to it.

(3) A relevant device falling within Class IIb may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Annex II, excluding Section 4 of that Annex, or

(ii)Annex III, together with Annex IV, V or VI;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it; and

(c)ensures that the device meets the provisions of Directive 93/42 which apply to it.

(4) A relevant device falling within Class III may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Annex II, or

(ii)Annex III, together with Annex IV or V;

(b)F631declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it; ...

(c)ensures that the device meets the provisions of Directive 93/42 which apply to it; [F632andF632]

[F633 (d)fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).F633]

F634(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F634(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Procedures for systems and procedure packs, and for devices to be sterilised before use E10

14.—(1) Subject to paragraph (3), no person shall supply a system or procedure pack (if that supply is also a placing on the market, or if that supply is of a system or procedure pack that has been placed on the market) unless—

(a)the medical devices in that system or procedure pack are for use within their intended purpose and within the limits of use specified by their manufacturer;

(b)the person who places or has placed it on the market has drawn up a declaration that—

(i)he has verified the mutual compatibility of the medical devices in that system or procedure pack in accordance with the manufacturers’ instructions, and he has carried out his operations in accordance with these instructions,

(ii)he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers, and

(iii)his production of the system or procedure pack is subjected to appropriate methods of internal control and inspection,

and that declaration is true at the time it is made and continues to be true.

(2) Subject to paragraph (3), no person shall supply—

(a)a system or procedure pack which was sterilised before being placed on the market; or

(b)a relevant device (including a system or procedure pack) which is designed by its manufacturer to be sterilised before use,

(if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless the person who places, or who has placed, the device on the market satisfies the conditions set out in paragraph (4).

(3) Paragraphs (1) and (2)(a) shall only apply to a system or procedure pack if, by virtue of regulation 12(3), regulation 10 does not apply to that system or procedure pack.

(4) The conditions referred to in paragraph (2) are that the person shall—

[F164 (a)follow the procedures referred to in either Annex II or IV that relate to obtaining sterility; andF164]

(b)if the device has been sterilised, make a written declaration that sterilisation has been carried out in accordance with the manufacturer’s instructions.

[F165 (4A) The application of Annex II or IV and the intervention of the [F166 approved bodyF166] are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged.F165]

(5) Where a conformity assessment procedure is carried out in respect of a relevant device (including a device which is a system or procedure pack) pursuant to this regulation—

(a)no person shall affix a [F167UK markingF167] to that device as a result of that procedure; and

(b)no person shall supply that device (if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless it is accompanied by the information referred to in Section 13 of Annex I, which shall include, where appropriate, the information supplied by the manufacturers of the devices which have been put together.

(6) The declarations referred to in paragraph (1)(b) and (4)(b) shall be kept available for the Secretary of State by the person responsible for placing the product on the market for a period of five years.

Procedures for systems and procedure packs, and for devices to be sterilised before use E58

14.—(1) Subject to paragraph (3), no person shall supply a system or procedure pack (if that supply is also a placing on the market, or if that supply is of a system or procedure pack that has been placed on the market) unless—

(a)the medical devices in that system or procedure pack are for use within their intended purpose and within the limits of use specified by their manufacturer;

(b)the person who places or has placed it on the market has drawn up a declaration that—

(i)he has verified the mutual compatibility of the medical devices in that system or procedure pack in accordance with the manufacturers’ instructions, and he has carried out his operations in accordance with these instructions,

(ii)he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers, and

(iii)his production of the system or procedure pack is subjected to appropriate methods of internal control and inspection,

and that declaration is true at the time it is made and continues to be true.

(2) Subject to paragraph (3), no person shall supply—

(a)a system or procedure pack which was sterilised before being placed on the market; or

(b)a relevant device (including a system or procedure pack) which is designed by its manufacturer to be sterilised before use,

(if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless the person who places, or who has placed, the device on the market satisfies the conditions set out in paragraph (4).

(3) Paragraphs (1) and (2)(a) shall only apply to a system or procedure pack if, by virtue of regulation 12(3), regulation 10 does not apply to that system or procedure pack.

(4) The conditions referred to in paragraph (2) are that the person shall—

[F635 (a)follow the procedures referred to in either Annex II or IV that relate to obtaining sterility; andF635]

(b)if the device has been sterilised, make a written declaration that sterilisation has been carried out in accordance with the manufacturer’s instructions.

[F636 (4A) The application of Annex II or IV and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged.F636]

(5) Where a conformity assessment procedure is carried out in respect of a relevant device (including a device which is a system or procedure pack) pursuant to this regulation—

(a)no person shall affix a CE marking to that device as a result of that procedure; and

(b)no person shall supply that device (if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless it is accompanied by the information referred to in Section 13 of Annex I, which shall include, where appropriate, the information supplied by the manufacturers of the devices which have been put together.

(6) The declarations referred to in paragraph (1)(b) and (4)(b) shall be kept available for the Secretary of State by the person responsible for placing the product on the market for a period of five years.

Procedures for custom-made general medical devices E11

15. No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or [F168their UK responsible personF168] —

(a)has drawn up a statement containing the information required by Sections 1, 2 and 2.1 of Annex VIII [F169, read with Regulation (EU) No 722/2012F169] ;

(b)has undertaken to keep available for the Secretary of State documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of Directive 93/42; and

(c)F170takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex VIII; ...

(d)keeps available for the Secretary of State, for a minimum period of five years, the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b) [F171; and

(e)ensures that the statement is passed on with the custom-made device so that it may be made available to the patient on request.F171]

Procedures for custom-made general medical devices E59

15. No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or his authorised representative—

(a)has drawn up a statement containing the information required by Sections 1, 2 and 2.1 of Annex VIII [F637, read with Regulation (EU) No 722/2012F637] ;

(b)has undertaken to keep available for the Secretary of State documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of Directive 93/42; and

(c)F638takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex VIII; ...

(d)keeps available for the Secretary of State, for a minimum period of five years, the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b) [F639; and

(e)ensures that the statement is passed on with the custom-made device so that it may be made available to the patient on request.F639]

Procedures for general medical devices for clinical investigations E12

16.—(1) Subject to paragraph (2), no person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in [F172Great BritainF172] unless, before he does so, the manufacturer of the device or [F173their UK responsible personF173] has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

(a)subject to paragraph (3), the statement required by [F174Sections 1 and 2.2F174] of Annex VIII [F175, read with Regulation (EU) No 722/2012F175] ; and

(b)an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.2 of Annex VIII for a minimum period of five years.

[F176 (1A) A manufacturer or their UK responsible person may request a meeting with the Secretary of State in advance of giving notice in writing to the Secretary of State pursuant to paragraph (1) in order to—

(a)obtain advice on regulatory requirements relating to an intended clinical investigation; or

(b)obtain a statistical review in relation to an intended clinical investigation.F176]

(2) Paragraph (1) shall not apply in respect of an intended clinical investigation of a relevant device that bears a [F177UK markingF177] otherwise than in breach of regulation 13, unless the aim of the intended investigation is to determine whether the device may be used for a purpose other than that in respect of which it was [F178UK markedF178] in accordance with regulation 13.

(3) The ethics committee opinion that forms part of the information required under Section 2.2 of Annex VIII need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or [F173their UK responsible personF173] as soon as it becomes available.

(4) If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer[F179 or UK responsible personF179] (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

(5) The Secretary of State may, in respect of notice in writing given by a manufacturer or [F173their UK responsible personF173] pursuant to paragraph (1), give written notice to the manufacturer or [F173their UK responsible personF173] —

(a)that the relevant device may be made available for the purposes of the intended investigation; or

(b)if the ethics committee opinion required under Section 2.2 of Annex VIII is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

(6) A written notice pursuant to paragraph (5) may—

(a)where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

(b)at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

(7) Where a written notice pursuant to paragraph (5) in respect of a relevant device has been withdrawn by the Secretary of State—

(a)further clinical use of the relevant device in the investigation is prohibited; and

(b)no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

(8) The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or [F173their UK responsible personF173] , shall—

(a)take all necessary measures to ensure that the manufacturing process for the relevant device produces devices manufactured in accordance with the documentation referred to in the first paragraph of Section 3.2 of Annex VIII;

(b)authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation; and

(c)keep the information contained in the statement and the undertaking referred to in paragraph (1) for a minimum period of five years.

(9) The grounds of public health or public policy referred to in paragraph (4) or (6)(b) are met, amongst other reasons, if—

(a)the manufacturer or [F173their UK responsible personF173] does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (8); or

(b)the manufacturer or [F173their UK responsible personF173] does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1)(b).

(10) No person shall conduct a clinical investigation of a relevant device—

(a)otherwise than in accordance with Annex X; and

(b)otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (6)(a),

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or [F173their UK responsible personF173] shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex X.

[F180 (11) The manufacturer, or their [F181 single UK responsible personF181] , shall—

(a)notify the Secretary of State of the end of the clinical investigation; and

(b)provide justification where premature termination has resulted.F180]

Procedures for general medical devices for clinical investigations E60

16.—(1) Subject to paragraph (2), no person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in [F640Northern IrelandF640] unless, before he does so, the manufacturer of the device or his authorised representative has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

(a)subject to paragraph (3), the statement required by [F641Sections 1 and 2.2F641] of Annex VIII [F642, read with Regulation (EU) No 722/2012F642] ; and

(b)an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.2 of Annex VIII for a minimum period of five years.

(2) Paragraph (1) shall not apply in respect of an intended clinical investigation of a relevant device that bears a CE marking otherwise than in breach of regulation 13, unless the aim of the intended investigation is to determine whether the device may be used for a purpose other than that in respect of which it was CE marked in accordance with regulation 13.

(3) The ethics committee opinion that forms part of the information required under Section 2.2 of Annex VIII need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or his authorised representative as soon as it becomes available.

(4) If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer or authorised representative (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

(5) The Secretary of State may, in respect of notice in writing given by a manufacturer or his authorised representative pursuant to paragraph (1), give written notice to the manufacturer or his authorised representative—

(a)that the relevant device may be made available for the purposes of the intended investigation; or

(b)if the ethics committee opinion required under Section 2.2 of Annex VIII is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

(6) A written notice pursuant to paragraph (5) may—

(a)where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

(b)at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

(7) Where a written notice pursuant to paragraph (5) in respect of a relevant device has been withdrawn by the Secretary of State—

(a)further clinical use of the relevant device in the investigation is prohibited; and

(b)no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

(8) The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or his authorised representative, shall—

(a)take all necessary measures to ensure that the manufacturing process for the relevant device produces devices manufactured in accordance with the documentation referred to in the first paragraph of Section 3.2 of Annex VIII;

(b)authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation; and

(c)keep the information contained in the statement and the undertaking referred to in paragraph (1) for a minimum period of five years.

(9) The grounds of public health or public policy referred to in paragraph (4) or (6)(b) are met, amongst other reasons, if—

(a)the manufacturer or his authorised representative does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (8); or

(b)the manufacturer or his authorised representative does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1)(b).

(10) No person shall conduct a clinical investigation of a relevant device—

(a)otherwise than in accordance with Annex X; and

(b)otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (6)(a),

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or his authorised representative shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex X.

[F643 (11) The manufacturer, or their single authorised representative, shall—

(a)notify the Secretary of State of the end of the clinical investigation; and

(b)provide justification where premature termination has resulted.F643]

Manufacturers etc. and conformity assessment procedures for general medical devices E13

17.—(1) A manufacturer of a relevant device or, where applicable, [F182their UK responsible personF182] who is required to follow, or follows or has followed a conformity assessment procedure set out in [F183this PartF183] shall observe the manufacturer’s obligations set out in that procedure that apply to him.

(2) A manufacturer of a relevant device or, where applicable, [F182their UK responsible personF182] shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with [F183this PartF183] at an intermediate stage of manufacture of the device.

F184(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F185(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F185(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturers etc. and conformity assessment procedures for general medical devices E61

17.—(1) A manufacturer of a relevant device or, where applicable, his authorised representative who is required to follow, or follows or has followed a conformity assessment procedure set out in Directive 93/42 shall observe the manufacturer’s obligations set out in that procedure that apply to him.

(2) A manufacturer of a relevant device or, where applicable, his authorised representative shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 93/42 at an intermediate stage of manufacture of the device.

F644(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F645(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F645(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F186Approved bodiesF186] and the conformity assessment procedures for general medical devices E14

18.—(1)[F187 An approved bodyF187] which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

(a)F188take account of the results of any assessment or verification operations which have been carried out ... at an intermediate stage of manufacture of the device;

(b)F189take account of any relevant information relating to the characteristics and performance of that device, ...; and

(c)lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annex II to IV.

(2) Where [F190an approved bodyF190] takes a decision in accordance with [F191Annex II, III, V or VI,F191] they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

(3) Where [F192an approved bodyF192] and a manufacturer or [F193the manufacturer’s UK responsible personF193] have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or [F193the manufacturer’s UK responsible personF193] , extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

F194(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

UK notified bodies and the conformity assessment procedures for general medical devices E62

18.—(1) A UK notified body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

(a)take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 93/42 at an intermediate stage of manufacture of the device;

(b)take account of any relevant information relating to the characteristics and performance of that device, including in particular the results of any relevant tests and verification relating to that device already carried out under the laws or administrative provisions in force before 1st January 1995 in any [F646EEA StateF646] ; and

(c)lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annex II to IV.

(2) Where a UK notified body takes a decision in accordance with [F647Annex II, III, V or VI,F647] they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

(3) Where a UK notified body and a manufacturer or his authorised representative have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or his authorised representative, extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

[F648 (4) Decisions taken by UK notified bodies before 1st September 2003 in accordance with Annex II in respect of breast implants may not be extended.F648]

[[F195,F196Registration of persons placing general medical devices on the market

19.—(1) Paragraph (2) applies—

(a)in relation to relevant devices that are neither Class I devices nor custom-made devices, to—

(i)a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any general medical device of any class, other than a system or procedure pack which is not CE marked;

F197(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

(iv)a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;

(b)in relation to Class I devices [F198 that are not custom-made devicesF198] , to—

(i)a manufacturer who places a device on the Northern Ireland market and has a registered place of business in Northern Ireland;

(ii)an authorised representative with a registered place of business in Northern Ireland;

(c)to a person with a registered place of business in Northern Ireland who sterilises before use any devices designed by their manufacturer to be sterilised before use.

(2) For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—

(a)inform the Secretary of State of their address and registered place of business;

(b)supply the Secretary of State with a description of each category of device concerned;

F199(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)in the case of an authorised representative, supply the Secretary of State with—

(i)written evidence that they have been designated as an authorised representative;

(ii)details of the person who has so designated them; and

(iii)where the person placing the devices concerned on the market is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market;

(e)inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.

(3) The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of any of the dates specified in paragraph (4) that apply in respect of a particular case.

(4) The obligations in paragraph (2) begin to apply—

(a)in the case of a device that is a Class I device and custom-made devices, on 1st January 2021;

(b)in the case of a device that is a Class III or IIb implantable device, on 1st May 2021;

(c)in the case of a device that is a Class IIa or Class IIb non-implantable device, on 1st September 2021.

F200(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F201(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F196,F195]]

Additional requirements relating to use of animal tissues

F20219A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[[F203,F204Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42

19B.—(1) In this regulation—

(a) “the Directive” means Directive 93/42 [F205 as it had effect on 25 May 2021 F205] and any reference to an Article or Annex is a reference to that Article or Annex in the Directive F206 ...;

(b) “Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it has effect in EU law;

(c) “CE marking” means the CE marking required by Article 17 and shown in Annex XII;

(d) “harmonised standard” is to be construed in accordance with Article 5.

(2) Where paragraph (3) applies regulations 8, 9, 10(1) to (4), 11 and 13 are treated as being satisfied.

(3)[F207 Subject to paragraph (3A),F207] this paragraph applies where, before placing a relevant device other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—

(a)ensures—

(i)that the device meets the essential requirements set out in Annex I and, where applicable, Regulation 722/2012, which apply to it; or

(ii)that paragraph (10) and (11) apply;

(b)ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 11;

[F208 (ba)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;F208]

(c)ensures that the documentation required by the conformity assessment procedure is drawn up;

(d)ensures that the technical and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;

(e)affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes II, III, IV, V, VI or VII;

(f)[F209 has drawn up before 26 May 2021F209] an EU declaration of conformity in accordance with Article 11; and

(g)ensures that the declaration of conformity is prepared in or translated into English.

[F210 (3A) Paragraph (3) only applies to a class I device under the Directive if—

(a)the conformity assessment procedure under Article 11 required the involvement of a notified body; or

(b)the conformity assessment procedure for that device under Article 52 of Regulation (EU) 2017/745 would require the involvement of a notified body (if it were to be assessed under that regulation).F210]

(4) Where paragraph (5) applies, regulations 8 and 15 are treated as being satisfied.

(5) This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—

(a)has drawn up a statement in English containing the information required by Section 1 and specified in Section 2.1 of Annex VIII, read with Regulation 722/2012;

(b)has undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow an assessment of conformity of the device with the requirements of the Directive;

(c)undertakes to the Secretary of State—

(i)to comply with Section 3.1 of Annex VIII;

(ii)to keep all documentation required by Annex VIII available in accordance with Section 4 of Annex VIII; and

(iii)to pass the statement mentioned in subparagraph (a) on with the custom-made device so that it may be made available to the patient on request.

(6) Where paragraph (7) applies, regulations 8 and 14 are treated as being satisfied.

(7) This paragraph applies where before a system or procedure pack is placed on the market, the manufacturer—

(a)has complied with Article 12(2);

(b)has complied with Article 12(3) and with the procedure in Annex II or V;

[F211 (ba)ensures that any certificate in relation to the system or procedure pack or a device within it that was issued by a notified body under the Directive is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;

(bb)ensures that the declarations required by Article 12 were drawn up before 26 May 2021;F211]

(c)undertakes to keep the declarations required by Article 12 for the period specified in Article 12(4); F212...

(d)ensures that the system or procedure pack is accompanied by the information referred to in point 13 of Annex I which must be in [F213 English; andF213]

[F214 (e)ensures that the system or procedure pack does not contain a class I device under the Directive for which—

(i)the conformity assessment procedure under Article 11 did not require the involvement of a notified body; and

(ii)the conformity assessment procedure under Article 52 of Regulation (EU) 2017/745 would not require the involvement of a notifed body (if it were to be assessed under that regulation).F214]

(8) Where paragraph (9) applies, regulations 8 and 16 are treated as being satisfied.

(9) This paragraph applies where before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—

(a)has provided the Secretary of State with the relevant written notice which must be in English in the form of the Statement required by Sections 1 and 2.2 of Annex VIII;

(b)undertakes to keep available the documentation referred to in Section 3.2 of Annex VIII for the period specified in Section 4 of that Annex; and

(c)has taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in the first paragraph of paragraph 3.1 of Annex VIII.

(10) Where paragraph (11) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4).

(11) This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.

(12) For the purpose of this regulation in regulations 10(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”. F204]

Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745

19C.—(1) In this regulation—

(a) “the Regulation” means Regulation (EU) 2017/745 , as it has effect in EU law, and any reference to an Article or an Annex is a reference to an Article or Annex of the Regulation;

(b) “CE marking” means the CE marking required by Article 20 and presented in Annex V;

(c) “harmonised standard” has the meaning given in Article 2(70);

(d) “sponsor” has the meaning given in Article 2(49).

(2) Where paragraph (3) applies, regulations 8, 10(1) to (4), 11, 13, 22, 23, 24 and 27 are treated as being satisfied.

(3) This paragraph applies where, before placing a relevant device within the meaning of Part II or Part III (as the case may be) other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—

(a)ensures—

(i)that the device meets the general safety and performance requirements in Annex I which apply to it; or

(ii)that paragraphs (10) and (11) apply;

(b)ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 52;

[F215 (ba)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;F215]

(c)ensures that the documentation required by the relevant conformity assessment procedure is drawn up;

(d)ensures that the technical documentation required by Annexes II and III and other relevant documentation required by a relevant conformity assessment procedure is prepared in or translated into English;

(e)affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes IX, X or XI;

(f)draws up an EU declaration of conformity in accordance with Article 19;

(g)ensures that the declaration of conformity is prepared in or translated into English.

(4) Where paragraph (5) applies regulations 8 and 15 (or as the case may be) 22 and 28 are treated as being satisfied.

(5) This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—

(a)has drawn up a statement in English containing the information specified in Section 1 of Annex XIII;

(b)has undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent national authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow assessment of the conformity of the device with the requirements of the Regulation; and

(c)undertakes to comply with Sections 3 (manufacturing), 4 (retention of information) and 5 (review of experience) of Annex XIII.

(6) Where paragraph (7) applies, regulations 8 and 14 are treated as being satisfied.

[F216 (7) This paragraph applies where, before a system or procedure pack is placed on the market, the person responsible for combining devices to produce that system or procedure pack—

(a)has complied with the relevant requirements of Article 22 including where that Article requires a conformity assessment in accordance with Annex IX or XI; and

(b)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn.F216]

(8) Where paragraph (9) applies, regulations 8 and 16(1) or (as the case may be) 22 and 29(1) are treated as being satisfied.

(9) This paragraph applies where, before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—

(a)has provided the Secretary of State with the required notice in the form of the application required by Article 70 in English; and

(b)has provided the Secretary of State with an undertaking to keep available documentation contained in the application in accordance with Section 3 of Chapter III of Annex XV.

(10) Where paragraph (11) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4) or regulation 23(4) (as the case may be).

(11) This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.

(12) For the purpose of this regulation in regulations 10(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”. F203]

PART III Active Implantable Medical Devices

Interpretation of Part III

F21720.—(1) In this Part...—

F217,F218,F218(2) In this Part..., a reference to a numbered ... Annex is to the ... Annex of Directive 90/385 bearing that number.

Scope of Part III E15

F22021.[F219—(1)F219] The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, ...

[F221 (2) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in [F222 Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008F222] to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.

[F223 (3) Where an active implantable device is intended to administer a medicinal product, that device must be governed by this Part without prejudice to the provisions of the Human Medicines Regulations 2012.F223,F221]]

F224(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Scope of Part III E63

21. [F649 —(1) F649] The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, except for devices that come within the scope of Directive 90/385 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

(a)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it; and

(b)the manufacturer chooses to follow the set of arrangements in the other Directive.

[F650 (2) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.

(3) Where an active implantable medical device is intended to administer a medicinal product, that device shall be governed by Directive 90/385 without prejudice to the provisions of dfnDirective 2001/83/EC.F650]

[F225Registration of persons placing active implantable medical devices on the market

21A.—(1) No person may place a relevant device on the market in accordance with this Part unless that person—

(a)is established in Great Britain; and

(b)has complied with paragraph (2).

(2) A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—

(a)where—

(i)that person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;

(ii)that person is the manufacturer of that device and is based outside the United Kingdom, and the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; or

(iii)that person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;

(b)that person supplies the Secretary of State with a description of the relevant device; and

(c)that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

(3) The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—

(a)ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b)keep available to the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c)in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d) where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access;

(e)where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;

(f)cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(g)immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;

(h)if the manufacturer acts contrary to its obligations under these Regulations—

(i)terminate the legal relationship with the manufacturer; and

(ii)inform the Secretary of State and, if applicable, the relevant approved body of that termination.

(4) In this regulation—

(a) the references to “technical documentation” are to be construed in accordance with Annex 2, 3 or 5;

(b) the references to “declaration of conformity” are to be construed in accordance with Annexes 2, 3 and 5. F225]

[F226Registration of persons placing active implantable medical devices on the market

21B.—(1) Paragraph (2) applies—

(a)in relation to relevant devices other than custom-made devices, to—

(i)a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any relevant device;

F227(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

(iv)a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;

F228(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—

(a)inform the Secretary of State of the address of their registered place of business; and

(b)supply the Secretary of State with a description of each category of device concerned;

F229(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)in the case of an authorised representative, supply the Secretary of State with—

(i)written evidence that they have been designated as an authorised representative;

(ii)details of the person who has so designated them; and

(iii)where the person placing the devices concerned on the market is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market;

(e)inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.

(3) The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of the date specified in paragraph (4).

(4) The obligations in paragraph (2) begin to apply on 1st May 2021.

F230(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F231(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F226]

Requirement to appoint a UK responsible person for active implantable medical devices

F23221C. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Essential requirements for active implantable medical devices

22.—(1) Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex 1 which apply to it [F233and the requirements set out in Regulation (EU) No 722/2012 (if applicable)F233] .

(2) Subject to regulation 26, no person shall supply a relevant device—

(a)if that supply is also a placing on the market or putting into service of that device; or

(b)in circumstances where that device has also been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex 1 which apply to it [F234and the requirements set out in Regulation (EU) No 722/2012 (if applicable)F234] .

Determining compliance of active implantable medical devices with relevant essential requirements E16

23.—(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

(2) Any—

(a)determination that a relevant device complies with any of the essential requirements set out in paragraphs 1 to 5 of Annex 1; and

(b)evaluation of side effects or undesirable effects for the purposes of determining whether or not a relevant device complies with any of the essential requirements,

shall be based in particular on clinical data, the adequacy of which is based on the collation of scientific literature or the results of clinical investigations referred to in paragraph 1 of Annex 7, and any determination as to whether or not a relevant device complies with any other essential requirements may be based on such data.

(3) In the case of a relevant device which is being or has been put into service—

(a)the essential requirements specified in paragraph 14 of Annex 1 are complied with only if the particulars there specified are in English (whether or not they are also in another language and whether or not the device is for professional use); and

(b)the essential requirements specified in paragraph 13 of Annex 1, so far as they relate to instructions required for the operation of a device in paragraph 15 of Annex 1, are complied with only if—

(i)F235the instructions are in English ...

F236(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant [F237designated standardF237] , unless there are reasonable grounds for suspecting that the device does not comply with that requirement.

(5) A custom-made device in respect of which the conditions specified in Annex 6 are satisfied and which is accompanied by the statement referred to in paragraph 1 of Annex 6 shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

(6) A device intended for clinical investigation in respect of which—

(a)the conditions specified in Annex 7 are satisfied;

(b)notice has been given under regulation 29(1); and

(c)either—

(i)no notice has been given under regulation 29(3) within the period of 60 days there referred to, or

(ii)notice has been given under regulation 29(4),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

Determining compliance of active implantable medical devices with relevant essential requirements E64

23.—(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

(2) Any—

(a)determination that a relevant device complies with any of the essential requirements set out in paragraphs 1 to 5 of Annex 1; and

(b)evaluation of side effects or undesirable effects for the purposes of determining whether or not a relevant device complies with any of the essential requirements,

shall be based in particular on clinical data, the adequacy of which is based on the collation of scientific literature or the results of clinical investigations referred to in paragraph 1 of Annex 7, and any determination as to whether or not a relevant device complies with any other essential requirements may be based on such data.

(3) In the case of a relevant device which is being or has been put into service—

(a)the essential requirements specified in paragraph 14 of Annex 1 are complied with only if the particulars there specified are in English (whether or not they are also in another language and whether or not the device is for professional use); and

(b)the essential requirements specified in paragraph 13 of Annex 1, so far as they relate to instructions required for the operation of a device in paragraph 15 of Annex 1, are complied with only if—

(i)the instructions are in English or another Community language, and

(ii)if the instructions are not in English, any packaging, label or promotional literature carries a clear statement in English stating the language in which the instructions are given.

(4) A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant national Standard, unless there are reasonable grounds for suspecting that the device does not comply with that requirement.

(5) A custom-made device in respect of which the conditions specified in Annex 6 are satisfied and which is accompanied by the statement referred to in paragraph 1 of Annex 6 shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

(6) A device intended for clinical investigation in respect of which—

(a)the conditions specified in Annex 7 are satisfied;

(b)notice has been given under regulation 29(1); and

(c)either—

(i)no notice has been given under regulation 29(3) within the period of 60 days there referred to, or

(ii)notice has been given under regulation 29(4),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

[F238UK markingF238] of active implantable medical devices E17

24.—(1) Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device or its sterile pack bears a [F239UK markingF239] which—

(a)meets the requirements set out in [F240Annex 2 of Regulation 765/2008F240] ;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant [F241approved bodyF241] or conformity assessment body identification number for that device.

(2) Subject to regulation 26, no person shall supply a relevant device unless that device or its sterile pack bears a [F239UK markingF239] which—

(a)meets the requirements set out in [F240Annex 2 of Regulation 765/2008F240] ;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant [F242approved bodyF242] or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.

(3) Subject to regulation 26, no person shall place on the market or put into service a relevant device unless a [F239UK markingF239] , meeting the requirements set out in [F240Annex 2 of Regulation 765/2008F240] , appears on—

(a)where appropriate, any sales packaging for that device; and

(b)the instructions for use for the device,

and that [F239UK markingF239] is accompanied by any relevant [F243approved bodyF243] or conformity assessment body identification number for that device.

(4) Subject to regulation 26, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a [F239UK markingF239] , meeting the requirements set out in [F240Annex 2 of Regulation 765/2008F240] , appears on—

(a)where appropriate, any sales packaging for that device; and

(b)the instructions for use for the device,

and that [F239UK markingF239] is accompanied by any relevant [F244approved bodyF244] or conformity assessment body identification number for that device.

(5) No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a)a relevant device or its sterile pack;

(b)the instructions for use for a relevant device; or

(c)where appropriate, any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the [F239UK markingF239] or which reduces the visibility or the legibility of the [F239UK markingF239] .

[F245 (6) In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—

(a)as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and

(b)as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).F245]

CE marking of active implantable medical devices E65

24.—(1) Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device or its sterile pack bears a CE marking which—

(a)meets the requirements set out in Annex 9;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(2) Subject to regulation 26, no person shall supply a relevant device unless that device or its sterile pack bears a CE marking which—

(a)meets the requirements set out in Annex 9;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.

(3) Subject to regulation 26, no person shall place on the market or put into service a relevant device unless a CE marking, meeting the requirements set out in Annex 9, appears on—

(a)where appropriate, any sales packaging for that device; and

(b)the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(4) Subject to regulation 26, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a CE marking, meeting the requirements set out in Annex 9, appears on—

(a)where appropriate, any sales packaging for that device; and

(b)the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(5) No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a)a relevant device or its sterile pack;

(b)the instructions for use for a relevant device; or

(c)where appropriate, any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the CE marking or which reduces the visibility or the legibility of the CE marking.

[F246UK(NI) indication: active implantable medical devices

24A.—(1) Where the CE marking referred to in regulation 24 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a)visibly, legibly and indelibly; and

(b)before a relevant medical device is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 27.

[F247 (3A) The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.F247]

(4) The UK(NI) indication must be affixed by the manufacturer.

(5) Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.

(6) No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service”;F246]

[F248UK marking of active implantable medical devices that come within the scope of this Part and other legislation E18

25. Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied. F248]

CE marking of active implantable medical devices that come within the scope of more than one Directive E66

25. Where a relevant device comes within the scope of Directive 90/385 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, no person shall affix a CE marking to the device unless the relevant requirements of the other Directive are also satisfied, except where—

(a)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it;

(b)the manufacturer chooses to follow the set of arrangements in Directive 90/385;

(c)the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and

(d)the particulars of Directive 90/385, as published in the Official Journal of the [F651European UnionF651] , are given in the documents, notices or instructions accompanying the device, and in a manner in which those particulars are accessible without it being necessary to destroy the packaging which keeps the device sterile.

Exemptions from regulations 22 and 24 E19

F24926.—(1) A relevant device being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of ... these Regulations.

(2) Regulation 24 shall not apply to a custom-made device or a device intended for clinical investigation.

(3) Regulations 22 and 24 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a [F250UK markingF250] , where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

[F251 (4) Regulations 22 and 24 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards or which is marked other than with a UK marking which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 22 and 24, may be placed on the market.

(5) In paragraph (4), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 22 and 24, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations. F251]

Exemptions from regulations 22 and 24 E67

26.—(1) A relevant device being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of Directive 90/385 or these Regulations.

(2) Regulation 24 shall not apply to a custom-made device or a device intended for clinical investigation.

(3) Regulations 22 and 24 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

Procedures for affixing a [F252UK markingF252] to active implantable medical devices E20

27. A relevant device may bear a [F253UK markingF253] only if its manufacturer or [F254their UK responsible personF254] —

(a)fulfils the applicable obligations imposed by—

(i)Annex 2, or

(ii)Annex 3, together with Annex 4 or 5;

(b)F256declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F255this PartF255] that apply to it; ...

(c)ensures that the device meets the provisions of [F255this PartF255] which apply to it; [F257andF257]

[F258 (d)fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).F258]

Procedures for affixing a CE marking to active implantable medical devices E68

27. A relevant device may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Annex 2, or

(ii)Annex 3, together with Annex 4 or 5;

(b)F652declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 90/385 that apply to it; ...

(c)ensures that the device meets the provisions of Directive 90/385 which apply to it; [F653andF653]

[F654 (d)fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).F654]

Procedures for custom-made active implantable medical devices E21

28. No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or [F259their UK responsible personF259] —

(a)has drawn up the statement containing the information required by Section 2.1 of Annex 6 [F260, read with Regulation (EU) No 722/2012F260] ;

(b)has undertaken to keep available for the Secretary of State the documentation referred to in Section 3.1 of Annex 6;

(c)takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex 6; and

(d)keeps available for the Secretary of State the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b).

Procedures for custom-made active implantable medical devices E69

28. No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or his authorised representative—

(a)has drawn up the statement containing the information required by Section 2.1 of Annex 6 [F655, read with Regulation (EU) No 722/2012F655] ;

(b)has undertaken to keep available for the Secretary of State the documentation referred to in Section 3.1 of Annex 6;

(c)takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex 6; and

(d)keeps available for the Secretary of State the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b).

Procedures for active implantable medical devices for clinical investigations E22

29.—(1) No person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in [F261Great BritainF261] unless, before he does so, the manufacturer of the device or [F262their UK responsible personF262] has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

(a)subject to paragraph (2), the statement required by Section 2.2 of Annex 6 [F263, read with Regulation (EU) No 722/2012F263] ; and

(b)an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.1 and 3.2 of Annex 6.

[F264 (1A) A manufacturer or their UK responsible person may request a meeting with the Secretary of State in advance of giving notice in writing to the Secretary of State pursuant to paragraph (1) in order to—

(a)obtain advice on regulatory requirements relating to an intended clinical investigation; or

(b)obtain a statistical review in relation to an intended clinical investigation.F264]

(2) The ethics committee opinion that forms part of the information required under Section 2.2 of Annex 6 need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or [F262their UK responsible personF262] as soon as it becomes available.

(3) If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer[F265 or UK responsible personF265] (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

(4) The Secretary of State may, in respect of notice in writing given by a manufacturer or [F262their UK responsible personF262] pursuant to paragraph (1), give written notice to the manufacturer or [F262their UK responsible personF262] —

(a)if the ethics committee opinion required under Section 2.2 of Annex 6 is favourable, that the relevant device may be made available for the purposes of the intended investigation; or

(b)if the ethics committee opinion required under Section 2.2 of Annex 6 is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

(5) A written notice pursuant to paragraph (4) may—

(a)where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

(b)at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

(6) Where a written notice pursuant to paragraph (4) in respect of a relevant device has been withdrawn by the Secretary of State—

(a)further clinical use of the relevant device in the investigation is prohibited; and

(b)no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

(7) The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or [F262their UK responsible personF262] , shall—

(a)take all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1, and the first paragraph of Section 3.2, of Annex 6;

(b)keep available for the Secretary of State the information contained in the statement and the undertaking referred to in paragraph (1); and

(c)authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation.

(8) The grounds of public health or public policy referred to in paragraphs (3) and (5)(b) are met, amongst other reasons, if—

(a)the manufacturer or [F262their UK responsible personF262] does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (7); or

(b)the manufacturer or [F262their UK responsible personF262] does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1).

(9) No person shall conduct a clinical investigation of a relevant device—

(a)otherwise than in accordance with Annex 7; and

(b)otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (5)(a),

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or [F262their UK responsible personF262] shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex 7.

[F266 (10) The manufacturer, or their [F267 single UK responsible personF267] , shall—

(a)notify the Secretary of State of the end of the clinical investigation; and

(b)provide justification where premature termination has resulted.F266]

Procedures for active implantable medical devices for clinical investigations E70

29.—(1) No person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in [F656Northern IrelandF656] unless, before he does so, the manufacturer of the device or his authorised representative has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

(a)subject to paragraph (2), the statement required by Section 2.2 of Annex 6 [F657, read with Regulation (EU) No 722/2012F657] ; and

(b)an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.1 and 3.2 of Annex 6.

(2) The ethics committee opinion that forms part of the information required under Section 2.2 of Annex 6 need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or his authorised representative as soon as it becomes available.

(3) If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer or authorised representative (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

(4) The Secretary of State may, in respect of notice in writing given by a manufacturer or his authorised representative pursuant to paragraph (1), give written notice to the manufacturer or his authorised representative—

(a)if the ethics committee opinion required under Section 2.2 of Annex 6 is favourable, that the relevant device may be made available for the purposes of the intended investigation; or

(b)if the ethics committee opinion required under Section 2.2 of Annex 6 is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

(5) A written notice pursuant to paragraph (4) may—

(a)where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

(b)at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

(6) Where a written notice pursuant to paragraph (4) in respect of a relevant device has been withdrawn by the Secretary of State—

(a)further clinical use of the relevant device in the investigation is prohibited; and

(b)no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

(7) The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or his authorised representative, shall—

(a)take all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1, and the first paragraph of Section 3.2, of Annex 6;

(b)keep available for the Secretary of State the information contained in the statement and the undertaking referred to in paragraph (1); and

(c)authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation.

(8) The grounds of public health or public policy referred to in paragraphs (3) and (5)(b) are met, amongst other reasons, if—

(a)the manufacturer or his authorised representative does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (7); or

(b)the manufacturer or his authorised representative does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1).

(9) No person shall conduct a clinical investigation of a relevant device—

(a)otherwise than in accordance with Annex 7; and

(b)otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (5)(a),

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or his authorised representative shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex 7.

[F658 (10) The manufacturer, or their single authorised representative, shall—

(a)notify the Secretary of State of the end of the clinical investigation; and

(b)provide justification where premature termination has resulted.F658]

Manufacturers etc. and conformity assessment procedures for active implantable medical devices E23

30.—(1) A manufacturer of a relevant device or, where applicable, [F268their UK responsible personF268] who is required to follow, or follows or has followed a conformity assessment procedure [F269in the Annexes referred to in regulation 27(a)F269] shall observe the manufacturer’s obligations set out in that procedure that apply to him.

F272(2) A manufacturer of a relevant device or, where applicable, [F270their UK responsible personF270] shall, when following a conformity assessment procedure [F271in the Annexes referred to in regulation 27(a)F271] , take account of the results of any assessment or verification operations which have been carried out ... at an intermediate stage of manufacture of the device.

F273(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F274(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F274(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturers etc. and conformity assessment procedures for active implantable medical devices E71

30.—(1) A manufacturer of a relevant device or, where applicable, his authorised representative who is required to follow, or follows or has followed a conformity assessment procedure set out in Directive 90/385 shall observe the manufacturer’s obligations set out in that procedure that apply to him.

(2) A manufacturer of a relevant device or, where applicable, his authorised representative shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 90/385 at an intermediate stage of manufacture of the device.

[F659 (3) Except as provided in paragraphs (4) and (5), the manufacturer of a relevant device, who under their own name places devices on the market, in accordance with the procedure referred to in Article 9(2) of Directive 90/385, shall provide the Secretary of State with—

(a)the address of their registered place of business;

(b)a description of the devices concerned; and

(c)details of the label and instructions for use that accompany each device.

(4) Where the manufacturer of a relevant device places a device on the market under their own name, but does not have a registered place of business in [F660 a relevant stateF660] , the manufacturer shall—

(a)designate a single authorised representative; and

(b)ensure that the authorised representative has a registered place of business in [F660 a relevant stateF660] .

(5) The authorised representative referred to in paragraph (4) shall provide the competent authority of [F661 the relevant stateF661] in which they have their registered place of business with the information referred to in paragraph (3) above.F659]

[F275Obligations in Part III which are met by complying with obligations in Directive 90/385

30A.—(1) In this regulation—

(a) “the Directive” means Directive 90/385 [F276 as it had effect on 25 May 2021 F276] and any reference to an Article or Annex is a reference to that Article or Annex in the Directive F277 ...;

(b) “Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it has effect in EU Law;

(c) “CE marking” means the CE marking required by Article 12 and shown in Annex 9;

(d) “harmonised standard” is to be construed in accordance with Article 5.

(2) Where paragraph (3) applies regulations 22, 24(1) to (4), 25 and 27 are treated as being satisfied.

(3) This paragraph applies where, before placing a relevant device other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—

(a)ensures—

(i)that the device meets the essential requirements set out in Annex I and, where applicable, Regulation (EU) 722/2012, which apply to it; or

(ii)that paragraphs (8) and (9) apply;

(b)ensures that the relevant conformity assessment procedure that applies to the device, where the device is a device other than those which are custom-made or intended for clinical investigations, has been carried out in accordance with Article 9;

[F278 (ba)ensures that the certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;F278]

(c)ensures that the documentation required by the relevant conformity assessment procedure is drawn up;

(d)ensures that the technical and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;

(e)affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes 2, 3, 4 or 5;

(f)[F279 has drawn up before 26 May 2021F279] an EU Declaration of Conformity in accordance with Article 9; and

(g)ensures that the declaration of conformity is prepared in or translated into English.

(4) Where paragraph (5) applies, regulations 25 and 28 are treated as being satisfied.

(5) This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—

(a)has drawn up a statement in English containing the information required by Section 1 and specified in Section 2.1 of Annex 6, read with Regulation 722/2012;

(b)has undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow an assessment of conformity of the device with the requirements of the Directive;

(c)undertakes to the Secretary of State—

(i)to comply with Section 3.1 of Annex 6;

(ii)to keep all documentation required by Annex 6 for the period specified in Section 4 of Annex 6; and

(iii)to pass on the statement mentioned in sub-paragraph (a) with the custom-made device so that it may be made available to the patient on request.

(6) Where paragraph (7) applies, regulations, 22 and 29 are treated as being satisfied.

(7) This paragraph applies where, before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—

(a)has provided the Secretary of State with the relevant written notice which must be in English in the form of the statement required by Section 2.2 of Annex 6;

(b)has provided an undertaking to keep available for five years the documentation referred to in Section 3.1 and 3.2 of Annex 6; and

(c)has taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in Section 3.2 of Annex 6.

(8) Where paragraph (9) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4).

(9) This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.

(10) For the purpose of this regulation in regulations 24(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”. F275]

[F280Approved bodiesF280] and the conformity assessment procedures for active implantable medical devices E24

31.—(1)[F281 An approved bodyF281] which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

(a)take account of the results of any assessment or verification operations which have been carried out in accordance with [F282this PartF282] at an intermediate stage of manufacture of the device; and

(b)lay down, by common accord with the manufacturer or [F283their UK responsible personF283] , the time limits for completion of the assessment and verification operations referred to in Annex 2 or 3.

(2) Where [F284an approved bodyF284] takes a decision in accordance with [F285Annex 2, 3 or 5F285] , they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

(3)[F286 Where an approved body and a manufacturer or the manufacturer’s UK responsible personF286] have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or [F287the manufacturer’s UK responsible personF287] , extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

UK notified bodies and the conformity assessment procedures for active implantable medical devices E72

31.—(1) A UK notified body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

(a)take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 90/385 at an intermediate stage of manufacture of the device; and

(b)lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annex 2 or 3.

(2) Where a UK notified body takes a decision in accordance with [F662Annex 2, 3 or 5F662] , they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

(3) Where a UK notified body and a manufacturer or his authorised representative have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or his authorised representative, extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

PART IV In Vitro Diagnostic Medical Devices

Interpretation of Part IV E25

F28832.—(1) In this Part ...—

F288(2) In this Part ..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.

Interpretation of Part IV E73

F66332.—(1) In this Part ...—

F663(2) In this Part ..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.

Scope of Part IV

33.—(1) The requirements of this Part in respect of relevant devices apply in respect ofin vitro diagnostic medical devices[F290 (including coronavirus test devices)F290] and accessories to such devices, except for—

(a)products manufactured and used within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity; [F291andF291]

(b) [F292 devices that come within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

(i)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

(ii)the manufacturer chooses to follow the set of arrangements in the other Directive.F292]

(2) The requirements of this Part in respect of devices for performance evaluation do not apply in respect of—

(a)products manufactured and used only within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity; [F293andF293]

(b) [F294 devices that come within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

(i)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

(ii)the manufacturer chooses to follow the set of arrangements in the other Directive.F294]

[F295Registration etc. of persons placing in vitro diagnostic medical devices on the market

33A.—(1) No person may place a relevant device on the market in accordance with this Part unless that person—

(a)is established in Great Britain; and

(b)has complied with paragraph (2).

(2) A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—

(a)where—

(i)that person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;

(ii)that person is the manufacturer of that device and is based outside the United Kingdom, the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; or

(iii)that person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;

(b)that person supplies the Secretary of State with—

(i)a description of the relevant device; and

(ii)the relevant information in paragraph (4); and

(c)that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

(3) The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—

(a)ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b)keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c)in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d) where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access;

(e)where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;

(f)cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(g)immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;

(h)if the manufacturer acts contrary to its obligations under these Regulations—

(i)terminate the legal relationship with the manufacturer; and

(ii)inform the Secretary of State and, if applicable, the relevant approved body of that termination.

(4) In this regulation “ relevant information ” means—

(a)in relation to a new relevant device, a statement indicating that the device is a new relevant device;

(b)if the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes;

(c)if the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications;

(d)in relation to devices in a list in Annex II and devices for self-testing—

(i)all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1;

(ii)if requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service;

(e)in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I.

(5) Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market.

(6) In this regulation a device is a “new relevant device” if—

(a)there has been no such device continuously available on the United Kingdom or EEA market during the previous three years for the relevant analyte or other parameter; or

(b)use of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or EEA market during the previous three years.

(7) In paragraph (3)—

(a) the references to “technical documentation” are to be construed in accordance with Annexes III to VIII;

(b) the references to “declaration of conformity” are to be construed in accordance with Annexes III, IV, V and VII. F295]

Essential requirements for in vitro diagnostic medical devices

34.—(1) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it.

(2) Subject to regulation 39, no person shall supply a relevant device—

(a)if that supply is also a placing on the market or putting into service of that device; or

(b)in circumstances where that device has been placed on the market or put into service, unless that device meets those essential requirements set out in Annex I which apply to it.

[F296Approval requirement for coronavirus test devices

34A.—(1) Subject to regulations [F297 34B to 34DF297] , 39(1) and 39A, no person other than the Secretary of State may place on the market or put into service a coronavirus test device, unless—

(a)the Secretary of State has approved it in accordance with regulation 38A(5); and

(b)the approval remains valid in accordance with regulation 38A(6).

(2) Subject to regulations [F298 34B to 34DF298] , 39(1) and 39A, no person other than the Secretary of State may supply a coronavirus test device—

(a)if that supply is also a placing on the market or putting into service of that device; or

(b)in circumstances where that device has been placed on the market or put into service,

unless the Secretary of State has approved it in accordance with regulation 38A(5) and the approval remains valid in accordance with regulation 38A(6).

(3) The requirements in paragraphs (1) and (2) are without prejudice to the other requirements of this Part.

Public sector use of coronavirus test devices

34B.—(1) Regulation 34A(1) does not apply in relation to a coronavirus test device that is placed on the market or put into service only for use by—

(a)the Secretary of State;

(b)a devolved public health body; or

(c)a health service body supplied pursuant to an existing contract.

(2) Regulation 34A(2) does not apply in relation to a coronavirus test device that is supplied to—

(a)the Secretary of State;

(b)a devolved public health body; or

(c)a health service body pursuant to an existing contract.

(3) In this regulation—

“a devolved public health body” is—

(a)

in Wales, Welsh Ministers or Public Health Wales National Health Service Trust;

(b)

in Scotland, Scottish Ministers;

(c)

in Northern Ireland, the Department of Health in Northern Ireland;

“an existing contract” is a contract entered into before the coming into force of regulation 34A;

“a health service body” is—

(a)

an NHS body as defined in section 275 of the National Health Service Act 2006 or in section 206 of the National Health Service (Wales) Act 2006;

(b)

a body listed in section 17A(2)(a) to (c) or (e) of the National Health Service (Scotland) Act 1978; or

(c)

a health and social care body as defined in section 1(5)(a) to (e) of the Health and Social Care (Reform) Act (Northern Ireland) 2009.

Transitional provisions for coronavirus test devices

34C.—(1) The requirements in regulation 34A do not apply in respect of any period before 1st September 2021.

(2) A person may place on the market, put into service or supply a coronavirus test device from 1st September 2021 until the end of 31st October 2021 if—

(a)that person has made an application to the Secretary of State in respect of that device, in accordance with regulation 38A; or

(b)that person is not—

(i)the manufacturer of the device,

(ii)a person acting as the manufacturer’s UK responsible person appointed for the purposes of regulation 33A or under regulation 44A, or

(iii)a person acting as the manufacturer’s authorised representative in Northern Ireland in accordance with regulation 44.F296]

[F299Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107

34D. Regulation 34A does not apply in Northern Ireland—

(a)in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746 and the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107;

(b)after 24 July 2024, in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746.F299]

Determining compliance of in vitro diagnostic medical devices with relevant essential requirements E26

35.—(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

F300(2) In order to meet the essential requirements set out in Section 8 of Part B of Annex I, the information to be provided under that Section must be in English ... .

(3) A relevant device shall be presumed to comply with an essential requirement if it conforms as respects that requirement to a relevant [F301designated standardF301] .

(4) A relevant device shall be treated as complying with an essential requirement in respect of which there is an applicable common technical specification only if it is in conformity with that specification or, if for duly justified reasons the manufacturer has not complied with that specification, an equivalent or higher specification.

Determining compliance of in vitro diagnostic medical devices with relevant essential requirements E74

35.—(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

(2) In order to meet the essential requirements set out in Section 8 of Part B of Annex I, the information to be provided under that Section must be in English if the device may reach a final user in [F665Northern IrelandF665] , unless—

(a)the Secretary of State, to the extent that Directive 98/79 allows him to do so, has authorised the use of another Community language or more than one other Community language; or

(b)the relevant device is a device for self-testing, in which case the instructions for use and the label must include a translation into the official language of any member State of the Community in which the device reaches a final user.

(3) A relevant device shall be presumed to comply with an essential requirement if it conforms as respects that requirement to a relevant national standard.

(4) A relevant device shall be treated as complying with an essential requirement in respect of which there is an applicable common technical specification only if it is in conformity with that specification or, if for duly justified reasons the manufacturer has not complied with that specification, an equivalent or higher specification.

[F302UK markingF302] of in vitro diagnostic medical devices E27

36.—(1) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device bears a [F303UK markingF303] which—

(a)meets the requirements set out in [F304Annex 2 of Regulation 765/2008F304] ;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant [F305approved bodyF305] or conformity assessment body identification number for that device.

(2) Subject to regulation 39, no person shall supply a relevant device unless, where practical and appropriate, that device bears a [F303UK markingF303] which—

(a)meets the requirements set out in [F304Annex 2 of Regulation 765/2008F304] ;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant [F305approved bodyF305] or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service or if that supply is of a device that has been placed on the market or put into service.

(3) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless a [F303UK markingF303] , meeting the requirements set out in [F304Annex 2 of Regulation 765/2008F304] , appears on—

(a)any sales packaging for that device; and

(b)the instructions for use for that device,

and that [F303UK markingF303] is accompanied by any relevant [F305approved bodyF305] or conformity assessment body identification number for that device.

(4) Subject to regulation 39, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a [F303UK markingF303] , meeting the requirements set out in [F304Annex 2 of Regulation 765/2008F304] , appears on—

(a)any sales packaging for that device; and

(b)the instructions for use for that device,

and that [F303UK markingF303] is accompanied by any relevant [F305approved bodyF305] or conformity assessment body identification number for that device.

(5) Subject to regulation 39, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a)a relevant device;

(b)the instructions for use for a relevant device; or

(c)any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the [F303UK markingF303] or which reduces the visibility or the legibility of the [F303UK markingF303] .

[F306 (6) In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—

(a)as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and

(b)as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).F306]

CE marking of in vitro diagnostic medical devices E75

36.—(1) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device bears a CE marking which—

(a)meets the requirements set out in Annex X;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(2) Subject to regulation 39, no person shall supply a relevant device unless, where practical and appropriate, that device bears a CE marking which—

(a)meets the requirements set out in Annex X;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service or if that supply is of a device that has been placed on the market or put into service.

(3) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless a CE marking, meeting the requirements set out in Annex X, appears on—

(a)any sales packaging for that device; and

(b)the instructions for use for that device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(4) Subject to regulation 39, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a CE marking, meeting the requirements set out in Annex X, appears on—

(a)any sales packaging for that device; and

(b)the instructions for use for that device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(5) Subject to regulation 39, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a)a relevant device;

(b)the instructions for use for a relevant device; or

(c)any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the CE marking or which reduces the visibility or the legibility of the CE marking.

[F307UK(NI) indication: in vitro diagnostic medical devices

36A.—(1) Where the CE marking referred to in regulation 36 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a)visibly, legibly and indelibly; and

(b)before a relevant medical device is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 36.

[F308 (3A) The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.F308]

(4) The UK(NI) indication must be affixed by the manufacturer.

(5) Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.

(6) No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service.F307]

[F309UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation E28

37. Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied. F309]

CE marking of in vitro diagnostic medical devices that come within the scope of more than one Directive E76

37. Where a relevant device comes within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, no person shall affix a CE marking to the device unless the relevant requirements of the other Directive are satisfied, except where—

(a)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it;

(b)the manufacturer chooses to follow the set of arrangements in Directive 98/79;

(c)the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and

(d)the particulars of Directive 98/79, as published in the Official Journal of the [F666European UnionF666] , are given in the documents, notices or instructions accompanying the device.

In vitro diagnostic medical devices not ready for use

38. Subject to regulation 39, no person shall—

(a)put into service a relevant device;

(b)supply a relevant device—

(i)if that supply is also a putting into service of that device, or

(ii)in circumstances where that device has been placed on the market or put into service,

which is not ready for use.

[F310Applications for approval of coronavirus test devices

38A.—(1) A person may make an application to the Secretary of State under this regulation for approval of a coronavirus test device.

(2) An application must include such information as the Secretary of State may require for the purposes of exercising their functions under—

(a)paragraph (5); and

(b)regulation 38C.

(3) An application must be made through the gov.uk website.

(4) The Secretary of State may treat an application made before the coming into force of this regulation as an application made under this regulation, if it meets the requirements of paragraph (2).

(5) The Secretary of State must approve a coronavirus test device if the Secretary of State is satisfied on the basis of the information contained in the application that the coronavirus test device meets the requirements of regulation 38B.

(6) An approval granted under paragraph (5) is valid for a period of 5 years, beginning with the day on which it is granted.

(7) Nothing in this regulation shall be taken to prevent—

(a)the Secretary of State;

(b)a weights and measures authority in Great Britain; or

(c)a district council in Northern Ireland,

from exercising a duty under regulation 61 to enforce these Regulations.

Performance requirements for coronavirus test devices

38B.—(1) The requirements that a coronavirus test device must meet for the purposes of regulation 38A(5) are set out in paragraphs (2) to (6).

(2) A coronavirus test device must be able to be put into service in accordance with this Part.

(3) A coronavirus test device that is an antigen test must have—

(a)a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 60%;

(b)a level of specificity, using a 95% two-sided confidence interval, that is entirely above 93%.

(4) A coronavirus test device that is a direct molecular test must have—

(a)a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 70%;

(b)a level of specificity, using a 95% two-sided confidence interval, that is entirely above 93%.

(5) A coronavirus test device that is an extracted molecular test must have—

(a)a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 93%;

(b)a level of specificity, using a 95% two-sided confidence interval, that is entirely above 97%.

(6) Where a coronavirus test device is also intended to detect the presence of anything other than a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the requirements in paragraphs (2) to (5) apply only in relation to its performance in detecting the presence of that viral antigen or viral ribonucleic acid (RNA).

(7) In this regulation and in regulation 38C—

“antigen test” means an dfnin vitro diagnostic medical device for the detection of the presence of a viral antigen specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

“direct molecular test” means an dfnin vitro diagnostic medical device which—

(a)

is for the detection of the presence of viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and

(b)

does not use a preliminary step of purification and concentration;

“extracted molecular test” means an dfnin vitro diagnostic medical device which—

(a)

is for the detection of the presence of viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and

(b)

uses a preliminary step of purification and concentration;

“sensitivity”, in relation to a coronavirus test device, means the proportion of true positives that are correctly identified by the test, calculated using the equation—

“specificity”, in relation to a coronavirus test device, means the proportion of true negatives that are correctly identified by the test, calculated using the equation—

Register of approved coronavirus test devices

38C.—(1) The Secretary of State must establish a register of coronavirus test devices which the Secretary of State has approved in accordance with regulation 38A.

(2) The Secretary of State must publish the register on the gov.uk website.

(3) The register must contain the following information in respect of each coronavirus test device—

(a)the name and address of the registered place of business of the person who made the application under regulation 38A;

(b)if the person who made the application was not the manufacturer, the name and address of the registered place of business of the manufacturer;

(c)the country in which the manufacturer is established;

(d)the name and address of the registered place of business of the UK responsible person or the manufacturer’s authorised representative having a registered place of business in Northern Ireland, if there is one in respect of the device;

(e)the name and description of the coronavirus test device;

(f)the date and version number of the instructions for use included in the application;

(g)whether the coronavirus test device is an antigen test, a direct molecular test, or an extracted molecular test;

(h)the date on which the coronavirus test device was approved in accordance with regulation 38A and the date on which that approval ceases to be valid.

(4) The register may contain such other information relating to the coronavirus test device and its intended use as the Secretary of State considers appropriate.F310]

Exemptions from [F311this PartF311] E29

39.—(1) A relevant device being shown at a trade fair, exhibition, scientific gathering or technical gathering is not being placed on the market or put into service if—

(a)the device is not used on any specimen taken from the participants; and

(b)F312a visible sign clearly indicates that the device cannot be marketed or put into service until it complies with the requirements of ... these Regulations.

(2) Regulations 34, 36 and 38 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a [F313UK markingF313] , where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

[F314 (3) Regulations 34 and 36 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards or which is marked other than with a UK marking which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 34 and 36, may be placed on the market.

(4) In paragraph (3), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 34 and 36, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations. F314]

Exemptions from regulations 34, 36 and 38 E77

39.—(1) A relevant device being shown at a trade fair, exhibition, scientific gathering or technical gathering is not being placed on the market or put into service if—

(a)the device is not used on any specimen taken from the participants; and

(b)a visible sign clearly indicates that the device cannot be marketed or put into service until it complies with the requirements of Directive 98/79 or these Regulations.

(2) Regulations 34, 36 and 38 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

[F315Exemptions for coronavirus test devices

39A.—(1) Regulation 34A does not apply where, in circumstances which give rise to a need to protect the public from a risk of serious harm to health, the Secretary of State—

(a)has decided to permit, where appropriate for a specified period, the placing on the market or putting into service of a particular coronavirus test device or coronavirus test devices of a particular class or description that has not been approved under regulation 38A(5); and

(b)has not withdrawn that permission.

(2) The Secretary of State may give permission under paragraph (1) subject to such conditions as are set out in a protocol published by the Secretary of State.

(3) If the Secretary of State publishes a protocol for the purpose of paragraph (2), the protocol must specify the period of time for which it has effect.

(4) The Secretary of State may withdraw or amend a protocol published under paragraph (2).F315]

Procedures for affixing a [F316UK markingF316] to in vitro diagnostic medical devices E30

40.—(1) A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a [F317UK markingF317] only if its manufacturer or [F318their UK responsible personF318] —

(a)fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;

(b)declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of [F319this PartF319] which apply to it; and

(c)ensures that the device meets the provisions of [F319this PartF319] which apply to it.

(2) A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a [F317UK markingF317] only if its manufacturer or [F318their UK responsible personF318] —

(a)fulfils the applicable obligations imposed by—

(i)Sections 1 to 6 of Annex III,

(ii)Annex IV, or

(iii)Annex V and either Annex VI or Annex VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F319this PartF319] which apply to it; and

(c)ensures that the device meets the provisions of [F319this PartF319] which apply to it.

(3) A relevant device referred to in List A in Annex II may bear a [F317UK markingF317] only if its manufacturer or [F318their UK responsible personF318] —

(a)fulfils the applicable obligations imposed by—

(i)Annex IV, or

(ii)Annexes V and VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F319this PartF319] which apply to it; and

(c)ensures that the device meets the provisions of [F319this PartF319] which apply to it.

(4) A relevant device referred to in List B in Annex II may bear a [F317UK markingF317] only if its manufacturer or [F318their UK responsible personF318] —

(a)fulfils the applicable obligations imposed by—

(i)Annex IV,

(ii)Annexes V and VI, or

(iii)Annexes V and VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F319this PartF319] which apply to it; and

(c)ensures that the device meets the provisions of [F319this PartF319] which apply to it.

Procedures for affixing a CE marking to in vitro diagnostic medical devices E78

40.—(1) A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;

(b)declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 98/79 which apply to it; and

(c)ensures that the device meets the provisions of Directive 98/79 which apply to it.

(2) A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Sections 1 to 6 of Annex III,

(ii)Annex IV, or

(iii)Annex V and either Annex VI or Annex VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

(c)ensures that the device meets the provisions of Directive 98/79 which apply to it.

(3) A relevant device referred to in List A in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Annex IV, or

(ii)Annexes V and VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

(c)ensures that the device meets the provisions of Directive 98/79 which apply to it.

(4) A relevant device referred to in List B in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Annex IV,

(ii)Annexes V and VI, or

(iii)Annexes V and VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

(c)ensures that the device meets the provisions of Directive 98/79 which apply to it.

Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices E31

41.—(1) A manufacturer of a relevant device or, where applicable, [F320their UK responsible personF320] who is required to follow, or follows or has followed a conformity assessment procedure set out in [F321this PartF321] shall observe the manufacturer’s obligations set out in that procedure [F322that apply to the manufacturer or, as the case may be, their UK responsible personF322] .

(2) A manufacturer of a relevant device or, where applicable, [F320their UK responsible personF320] shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with [F321this PartF321] at an intermediate stage of manufacture of the device.

(3) A manufacturer or, where applicable, [F320their UK responsible personF320] shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Secretary of State—

(a)the declaration of conformity for that device;

(b)the technical documentation referred to in Annexes III to VIII relating to that device; and

(c)the decisions, reports and certificates of [F323approved bodiesF323] relating to that device,

for a period ending five years after the manufacture of the last product.

M6(4) A person who in the course of manufacturing relevant devices or devices for performance evaluation removes, collects, or uses tissues, cells or substances of human origin shall, in the course of removing, collecting or using those tissues, cells or substances act in accordance with the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine .

F324(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices E79

41.—(1) A manufacturer of a relevant device or, where applicable, his authorised representative who is required to follow, or follows or has followed a conformity assessment procedure set out in Directive 98/79 shall observe the manufacturer’s obligations set out in that procedure that apply to him.

(2) A manufacturer of a relevant device or, where applicable, his authorised representative shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 98/79 at an intermediate stage of manufacture of the device.

(3) A manufacturer or, where applicable, his authorised representative shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Secretary of State—

(a)the declaration of conformity for that device;

(b)the technical documentation referred to in Annexes III to VIII relating to that device; and

(c)the decisions, reports and certificates of notified bodies relating to that device,

for a period ending five years after the manufacture of the last product.

M18(4) A person who in the course of manufacturing relevant devices or devices for performance evaluation removes, collects, or uses tissues, cells or substances of human origin shall, in the course of removing, collecting or using those tissues, cells or substances act in accordance with the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine .

(5) Until the European databank referred to in article 12 has been established, the manufacturer or, where applicable, his authorised representative shall, in respect of any relevant device which the manufacturer has placed on the market [F667in Northern IrelandF667] , provide the Secretary of State with the data referred to in article 12(1)(a), and that data shall be provided in English.

[F325Approved bodiesF325] and the conformity assessment procedures for in vitro diagnostic medical devices

42.—(1)[F326 An approved bodyF326] which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

(a)F327take account of the results of any assessment or verification operations which have been carried out ... at an intermediate stage of manufacture of the device;

(b)F328take account of any relevant information relating to the characteristics and performance of that device, ...; and

(c)lay down, by common accord with the manufacturer or [F329their UK responsible personF329] , the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.

(2) Where [F330an approved bodyF330] takes a decision in accordance with Annex III, IV, or V, they shall specify the period of validity of the decision, which, initially, shall be a period of not more than 5 years.

(3) Where [F331an approved bodyF331] and a manufacturer or [F332their UK responsible personF332] have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or [F332their UK responsible personF332] , extend the period of validity of the decision for further periods of up to 5 years, each such period commencing on the expiry of the previous period.

UK notified bodies and the conformity assessment procedures for in vitro diagnostic medical devices

42.—(1) A UK notified body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

(a)take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 98/79 at an intermediate stage of manufacture of the device;

(b)take account of any relevant information relating to the characteristics and performance of that device, including in particular the results of any relevant tests and verification relating to that device already carried out before 7th June 2000; and

(c)lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.

(2) Where a UK notified body takes a decision in accordance with Annex III, IV, or V, they shall specify the period of validity of the decision, which, initially, shall be a period of not more than 5 years.

(3) Where a UK notified body and a manufacturer or his authorised representative have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or his authorised representative, extend the period of validity of the decision for further periods of up to 5 years, each such period commencing on the expiry of the previous period.

Devices for performance evaluation E32

43. No person shall supply a device for performance evaluation (if that supply is also a making available of the device) unless the manufacturer or [F333their UK responsible personF333] —

(a)has drawn up a statement containing the information required by Section 2 of Annex VIII and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;

(b)ensures that—

(i)the device conforms with the documentation mentioned in the said section 2, and

(ii)the relevant requirements of [F334these RegulationsF334] are complied with as respects that device; and

(c)undertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation, documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.

Devices for performance evaluation E80

43. No person shall supply a device for performance evaluation (if that supply is also a making available of the device) unless the manufacturer or his authorised representative—

(a)has drawn up a statement containing the information required by Section 2 of Annex VIII and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;

(b)ensures that—

(i)the device conforms with the documentation mentioned in the said section 2, and

(ii)the relevant requirements of the Directive are complied with as respects that device; and

(c)undertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation, documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.

[[F335,F336Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation

44.—(1) Paragraph (2) applies—

(a)in relation to relevant devices that are Annex II devices or devices for self-testing, to—

(i)a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland, or makes available for performance evaluation, any relevant device;

F337(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

(iv)a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;

(b)in relation to relevant devices other than Annex II devices or devices for self-testing, to—

(i)a manufacturer who places a device on the Northern Ireland market, or makes such a device available for performance evaluation, and has a registered place of business in Northern Ireland;

(ii)an authorised representative with a registered place of business in Northern Ireland.

(2) For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—

(a)inform the Secretary of State of the address of their registered place of business; and

(b)supply the Secretary of State with—

(i)a description of each category of device concerned;

(ii)the relevant information in paragraph (7);

F338(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)in the case of an authorised representative, supply the Secretary of State with—

(i)written evidence that they have been designated as an authorised representative;

(ii)details of the person who has so designated them; and

(iii)where the person placing the devices concerned on the market, or making them available for performance evaluation, is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market, or making them available for performance evaluation;

(e)inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.

(3) The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of any of the dates specified in paragraph (4) that apply in respect of a particular case.

(4) The obligations in paragraph (2) begin to apply—

(a)where a device is being placed on the market by a manufacturer with a registered place of business in Northern Ireland or by a person who has designated an authorised representative with a registered place of business in Northern Ireland, on 1st January 2021;

(b)in circumstances other than those described in sub-paragraph (a)—

(i)in the case of a relevant device that is a List A device, on 1st May 2021;

(ii)in the case of a relevant device that is a device for self-testing, on 1st September 2021; and

(iii)in the case of a relevant device that is a List B device, on 1st September 2021.

F339(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F340(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) In this regulation “relevant information” means—

(a)in relation to a new relevant device, a statement indicating that the device is a new relevant device;

(b)if the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes;

(c)if the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications;

(d)in relation to devices in a list in Annex II and devices for self-testing—

(i)all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1;

(ii)if requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service;

(e)in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I.

(8) Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market.

(9) In paragraphs (7) and (8) a device is a “new relevant device” if—

(a)there has been no such device continuously available on the United Kingdom or EEA market during the previous three years for the relevant analyte or other parameter; or

(b)use of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or EEA market during the previous three years.F336,F335]]

[[F341,F342Obligations in Part IV which are met by complying with obligations in Directive 98/79

44ZA—(1) In this regulation—

(a)any reference to an Article or Annex is a reference to that Article or Annex in Directive 98/79 as [F343 it had effect on 25 May 2022F343] ;

(b) “Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it applies in the European Union;

(c) “CE marking” means the CE marking required by Article 16 and shown in Annex X;

(d) “harmonised standard” is to be construed in accordance with Article 5.

(2) Where paragraph (3) applies regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied.

(3)[F344 Subject to to paragraph (3A),F344] this paragraph applies where, before placing a relevant device on the market, the manufacturer—

(a)ensures—

(i)that the device meets the essential requirements set out in Annex I and, where applicable, Regulation (EU) 722/2012, which apply to it; or

(ii)that paragraphs (6) and (7) apply;

(b)ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 9;

[F345 (ba)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 110(2) of Regulation (EU) 2017/746;F345]

(c)ensures that the documentation required by the relevant conformity assessment procedure is drawn up;

(d)ensures that the technical and other relevant documentation required by a relevant conformity assessment procedure is prepared in or translated into English;

(e)affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes III, IV, V, VI or VII;

(f)[F346 has drawn up before 26 May 2022F346] an EU Declaration of Conformity in accordance with Article 9;

(g)ensures that the declaration of conformity is prepared in or translated into English.

[F347 (3A) Paragraph (3) only applies to a relevant device for which the conformity assessment procedure under Article 9 did not require the involvement of a notified body, if the conformity assessment procedure for that device under Article 48 of Regulation (EU) 2017/746 would require the involvement of a notified body.F347]

(4) Where paragraph (5) applies, regulation 43 is treated as being satisfied.

(5) This paragraph applies where before a relevant device intended for performance evaluation is made available in Great Britain for the purpose of a performance evaluation, the manufacturer—

(a)has supplied the relevant written notice which must be in English in the form required by Sections 1 and 2 of Annex VIII;

(b)has provided an undertaking to the Secretary of State to keep available the documentation required by Annex VIII for the period specified in Section 3 of Annex VIII;

(c)has taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in the first paragraph of Section 3 of Annex VIII.

(6) Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4).

(7) This paragraph applies where—

(a)a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard; or

(b)a relevant device is in conformity with a common technical specification.

(8) For the purpose of this regulation in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”. F342,F341]]

[F342Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746

44ZB.—(1) In this regulation—

(a)any reference to an Article or Annex is a reference to that Article or Annex in Regulation (EU) 2017/746 as it has effect in EU law;

(b) “CE marking” means the CE marking required by Article 18 and presented in Annex V;

(c) “harmonised standard” has the meaning given in Article 2(73);

(d) “sponsor” has the meaning given in Article 2(57).

(2) Where paragraph (3) applies, regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied.

(3) This paragraph applies where, before placing a relevant device on the market, the manufacturer—

(a)ensures—

(i)that the device meets the general safety and performance requirements in Annex I which apply to it; or

(ii)that paragraphs (6) and (7) apply;

(b)ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 48;

[F348 (ba)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;F348]

(c)ensures that the documentation required by the relevant conformity assessment procedure is drawn up;

(d)ensures that the technical documentation required by Annexes II and III and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;

(e)affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedures set out in Annexes IX, X and XI;

(f)draws up an EU declaration of conformity in accordance with Article 17; and

(g)ensures that the declaration of conformity is prepared in or translated into English.

(4) Where paragraph (5) applies, regulation 43 is treated as being satisfied.

(5) This paragraph applies where, before a person supplies or makes available a device falling within Part IV for the purposes of performance evaluation, the sponsor of the performance evaluation—

(a)has been able to provide the Secretary of State with the required notice in the form of the application required by Chapter I of Annex XIV in English;

(b)has been able to provide the Secretary of State with an undertaking to keep available information contained in the application in accordance with Chapter II of Annex XIV.

(6) Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4).

(7) This paragraph applies where—

(a)a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard; or

(b)a relevant device is in conformity with a common technical specification.

(8) For the purpose of this regulation, in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”. F342]

[F349PART 4A Post-market surveillance requirements

Interpretation of Part 4A

44ZC. In this Part—

“ corrective action ” means action taken in order to—

(a)

eliminate the cause of a potential or actual non-conformity of a device, or

(b)

reduce any other risk posed by a device,

that has already been manufactured and may include recalling the device, withdrawing it from the market, and taking it out of service;

“ field safety corrective action ” means a corrective action taken by the manufacturer to prevent or reduce the risk of a serious incident in relation to a device which has already been placed on the market or put into service;

“ incident ” means in relation to a device that has been placed on the market or put into service—

(a)

a malfunction or deterioration in the characteristics or performance of the device when used in accordance with the instructions for use,

(b)

a side-effect that has a negative impact on—

(i)

the health of an individual,

(ii)

patient management, or

(iii)

public health,

(c)

an inadequacy in the design of the device, including an ergonomic feature, to enable the user to use the device safely and as intended by the manufacturer,

(d)

an inadequacy in the information supplied with the device by the manufacturer to enable the user to use the device safely and as intended by the manufacturer, or

(e)

an erroneous result provided by a diagnostic medical device, which informs a decision in relation to medical treatment;

“ lifetime of a device ” means the shelf life of a device (if there is one) plus the period that the manufacturer expects that device to perform as intended;

“ PMS period ” means the period—

(a)

beginning with the day on which the first device of a device model is put into service by the manufacturer or placed on the market, whichever is sooner, and

(b)

ending with the end of the lifetime of the last device of that device model that is put into service by the manufacturer or placed on the market, whichever is later;

“ post-market surveillance ” means activities carried out by manufacturers to proactively collect and review experience gained from devices placed on the market or put into service for the purposes of identifying any need to apply corrective or preventive actions;

“ preventive action ” means action taken by the manufacturer before completion of the manufacturing phase in order to eliminate the cause of a potential non-conformity or reduce a potential risk that could be posed by the finished device;

“ Regulation (EU) No 722/2012 ” means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin, as it had effect in the EU on 25 May 2021;

“ relevant device ” means a device that is a “ relevant device ” for the purposes of Part 2, 3 or 4;

“ relevant essential requirements ” means—

(a)

in relation to a device placed on the market in accordance with regulation 19B, the essential requirements set out in Annex I of Directive 93/42 and, where applicable, Regulation (EU) No 722/2012 which apply to it;

(b)

in relation to a device placed on the market in accordance with regulation 19C, the general safety and performance requirements set out in Annex I of Regulation (EU) 2017/745 which apply to it;

(c)

in relation to a device otherwise placed on the market or put into service in accordance with Part 2, the requirements referred to in regulation 8 (essential requirements for general medical devices) which apply to it;

(d)

in relation to a device placed on the market in accordance with regulation 30A, the essential requirements set out in Annex I of Directive 90/385 and, where applicable, Regulation (EU) No 722/2012 which apply to it;

(e)

in relation to a device otherwise placed on the market or put into service in accordance with Part 3, the requirements referred to in regulation 22 (essential requirements for active implantable medical devices) which apply to it;

(f)

in relation to a device placed on the market in accordance with regulation 44ZA, the essential requirements set out in Annex I of Directive 98/79 which apply to it;

(g)

in relation to a device placed on the market in accordance with regulation 44ZB, the general safety and performance requirements set out in Annex I of Regulation (EU) 2017/746 which apply to it;

(h)

in relation to a device otherwise placed on the market or put into service in accordance with Part 4, the essential requirements referred to in regulation 34 (essential requirements for in vitro diagnostic medical devices) which apply to it;

“ required risk analysis ” means the analysis required to weigh the risks posed by a device against the intended performance and benefits for the purposes of confirming conformity with the relevant essential requirements;

“ serious deterioration of any person’s state of health ” means any of the following—

(a)

life-threatening illness or injury;

(b)

permanent impairment of a body structure or a body function;

(c)

hospitalisation or prolongation of hospitalisation;

(d)

medical treatment, including surgical intervention and self-administered treatment, that is required to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function;

(e)

chronic disease;

(f)

foetal distress, foetal death or a congenital physical or mental impairment or birth defect;

“ serious incident ” means an incident that directly or indirectly led, might have led or might lead to any of the following—

(a)

the death of any person;

(b)

the serious deterioration of any person’s state of health;

(c)

a serious public health threat;

“ serious public health threat ” means an event which could result in a risk—

(a)

of death, serious illness, or serious deterioration of any person’s state of health,

(b)

that affects a significant population, and

(c)

that requires prompt remedial action;

“ similar device ” means a device which—

(a)

has the same or a similar intended purpose, and

(b)

is based on the same or similar technology;

“ system or procedure pack ” has the same meaning as in regulation 5(1).

Scope of Part 4A

44ZD.—(1) Subject to paragraphs (2) and (3), the requirements of this Part apply in respect of relevant devices that are—

(a)put into service by the manufacturer, or

(b)placed on the market,

in accordance with Parts 2, 3 or 4 on or after the date on which the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 come into force.

(2) The following regulations in this Part apply in respect of custom-made devices—

(a)regulation 44ZC (interpretation of Part 4A);

(b)regulation 44ZE (post-market surveillance system);

(c)regulation 44ZF (post-market surveillance plan) except paragraphs (3)(g) and (h);

(d)regulation 44ZG (preventive and corrective actions);

(e)regulation 44ZH (initial reporting of serious incidents);

(f)regulation 44ZI (investigation and final reporting of serious incidents);

(g)regulation 44ZJ (field safety corrective actions and field safety notices);

(h)regulation 44ZO (reports received by the Secretary of State);

(i)regulation 44ZP (analysis of information received under Part 4A);

(j)regulation 44ZQ (retention of post-market surveillance documentation);

(k)regulation 44ZR (requests for post-market surveillance documentation).

(3) This Part does not apply to—

(a)devices intended for clinical investigation or performance evaluation;

(b)devices placed on the market or put into service in accordance with an authorisation issued by the Secretary of State under regulation 12(5), 26(3) or 39(2).

(4) In this Part, the relevant devices to which this Part applies are referred to as “ devices ”.

(5) In this regulation, “ custom-made device ” means a device within the meaning of that term as defined in regulation 5 or regulation 20.

Post-market surveillance system

44ZE. —(1) The manufacturer must maintain a post-market surveillance system (“PMS system”) for each device that is placed on the market or put into service.

(2) The manufacturer must ensure the PMS system—

(a)is proportionate to the risk posed by the device;

(b)is appropriate to the type of device;

(c)includes the analysis of data relevant to the quality, performance and safety of the device throughout its lifetime, and a record of the manufacturer’s conclusions based on that analysis.

(3) The manufacturer must ensure that the PMS system is used throughout the PMS period to identify—

(a)preventive actions and corrective actions, including field safety corrective actions;

(b)trends in incidents, including those on which the manufacturer must report under regulation 44ZN (trend reporting);

(c)options to improve the usability, performance and safety of the device;

(d)any impact on the post-market surveillance of other devices.

(4) The manufacturer must ensure that data gathered through the PMS system is used to update the following—

(a)for devices placed on the market or put into service in accordance with Part 2 or 3—

(i)the instructions for use and labelling of the device;

(ii)design and manufacturing information;

(iii)the required risk analysis;

(iv)the evaluation of clinical data referred to in regulations 9(2) and 23(2) for the purposes of confirming conformity with the relevant essential requirements;

(v)any other technical documentation required by the conformity assessment procedure carried out in respect of the device in accordance with Part 2 or 3.

(b)for devices placed on the market or put into service in accordance with Part 4—

(i)the instructions for use and labelling of the device;

(ii)design and manufacturing information;

(iii)the required risk analysis;

(iv)any evaluation of performance evaluation data confirming conformity with the relevant essential requirements;

(v)any other technical documentation required by the conformity assessment procedure carried out in respect of the device in accordance with Part 4.

(5) Paragraph (4) does not apply in respect of a device placed on the market in accordance with regulation 19B, 19C, 30A, 44ZA or 44ZB.

Post-market surveillance plan

44ZF. —(1) The manufacturer must base the post-market surveillance system on a post-market surveillance plan (“PMS plan”) that complies with this regulation.

(2) A PMS plan must be—

(a)clear, organised and searchable, and

(b)maintained for the PMS period of the device model.

(3) A PMS plan must specify the lifetime of the device and must include—

(a)processes for the collection and assessment of the following information in relation to the device—

(i)information about serious incidents, other incidents and side-effects;

(ii)information about field safety corrective actions;

(iii)information for the purposes of identifying trends in incidents and if applicable, reporting those trends under regulation 44ZN (trend reporting);

(iv)feedback and complaints provided by users and suppliers of the device;

(v)information about user experience in relation to safety and performance, including through patient and public engagement, where appropriate;

(vi)other information relevant to the post-market surveillance of the device, including information relating to similar devices available on the market and available outside Great Britain.

(b)suitable indicators and threshold values to be used in the reassessment of the required risk analysis;

(c)effective and appropriate processes to investigate complaints and analyse feedback and information about user experience;

(d)processes to manage incidents and trends (whether or not they must be reported under regulation 44ZN (trend reporting)), including—

(i)the statistical methodology to be used to determine a significant increase in the frequency or severity of incidents, and

(ii)in relation to a device placed on the market or put into service in accordance with Part 4, the statistical methodology to be used to determine a significant increase in expected erroneous results;

(e)a process for communicating effectively with the Secretary of State, the approved body for the device (if there is one), the UK responsible person (if there is one), users and suppliers of the device;

(f)processes that provide for how the manufacturer will comply with their obligations under this Part;

(g)a plan for any post-market clinical follow-up required under Part 2 or 3;

(h)the post-market surveillance report required by regulation 44ZL (post-market surveillance report) or the periodic safety update report required by regulation 44ZM (periodic safety update report) and any reports issued by an approved body under paragraph (9) of regulation 44ZM.

(4) The information collected under paragraph (3)(a) must enable—

(a)an accurate characterisation of the performance of the device, and

(b)a comparison between the device and similar devices available on the market.

(5) The manufacturer and the UK responsible person (if there is one) must provide the PMS plan, including any post-market surveillance reports or periodic safety update reports and any reports issued by an approved body, to the Secretary of State upon request and within 3 working days of the date of any such request.

Preventive and corrective actions

44ZG.—(1) If the manufacturer of a device—

(a)identifies a risk that following evaluation is deemed to compromise the performance or safety of the device, or

(b)otherwise has reason to believe that the device is not in conformity with the relevant essential requirements,

they must take the necessary preventive or corrective action as soon as possible to reduce that risk and bring the device into conformity.

(2) The manufacturer must notify the action to—

(a)the UK responsible person (if there is one);

(b)the approved body for the device (if there is one);

(c)if the action is a field safety corrective action, the Secretary of State in accordance with regulation 44ZJ (field safety corrective action).

(3) The approved body must review the notification to determine whether there is any impact on the certification it has issued for the device.

(4) The manufacturer must monitor the action to identify if any further action is required to reduce the risk posed and bring the device into conformity.

Initial reporting of serious incidents

44ZH.—(1) The manufacturer must report to the Secretary of State any serious incident involving the manufacturer’s device.

(2) The report must include—

(a)the manufacturer’s name and contact details;

(b)the UK responsible person’s name and contact details (if there is one);

(c)details of the initial reporter of the serious incident;

(d)a description of the device, including its current location and any unique device identifiers;

(e)a description of the serious incident;

(f)the manufacturer’s preliminary conclusions in relation to the cause of the serious incident;

(g)consideration of whether any field safety corrective action is required to prevent or reduce the risk of a further serious incident;

(h)details of any preventive or corrective action taken by the manufacturer.

(3) The manufacturer must submit the report—

(a)immediately after the manufacturer has established the causal (or reasonably possible causal) relationship between the device and the serious incident, and

(b)unless paragraph (4) or (5) applies, no later than 15 days after the manufacturer becomes aware of the serious incident.

(4) If the serious incident being reported involves a serious public health threat, the report must be submitted no later than 2 days after the manufacturer becomes aware of the threat.

(5) If there is a death or an unanticipated serious deterioration in a person’s state of health, the report must be submitted no later than 10 days after the manufacturer becomes aware of the incident.

(6) If the same device model or a variant of that model is involved in similar serious incidents and the manufacturer has either—

(a)identified the cause, or

(b)implemented a field safety corrective action,

the manufacturer and the Secretary of State may agree that the manufacturer can submit periodic summary reports instead of individual serious incident reports.

Investigation and final reporting of serious incidents

44ZI.—(1) After submitting a serious incident report under regulation 44ZH (initial reporting of serious incidents), the manufacturer must as soon as possible—

(a)investigate the serious incident and the device or devices concerned,

(b)review the required risk analysis for the device or devices concerned taking into account the serious incident and any proposed preventive and corrective actions, and

(c)submit a final report to the Secretary of State setting out—

(i)the methods and conclusions of the investigation;

(ii)consideration of whether any field safety corrective action is required to prevent or reduce the risk of a further serious incident;

(iii)details of any field safety corrective action the manufacturer has taken or intends to take;

(iv)details of similar serious incidents involving the same device model or a variant of that model.

(2) The Secretary of State may—

(a)give advice to a manufacturer regarding the serious incident investigation;

(b)initiate a separate investigation;

(c)require the approved body (if there is one) to provide information and assessments relevant to the serious incident and field safety corrective action.

(3) A manufacturer must—

(a)cooperate with the Secretary of State in relation to the investigations referred to in paragraphs (1)(a) and (2)(b);

(b)upon request, provide the Secretary of State with updates and documents relevant to an investigation referred to in paragraphs (1)(a) and (2)(b) and do so within 3 working days of the date of any such request;

(c)not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the serious incident, before informing the Secretary of State of such action.

Field safety corrective actions and field safety notices

44ZJ. —(1) Unless paragraph (4) applies, before taking any field safety corrective action (“ FSCA ”) in relation to a device, a manufacturer must—

(a)produce a risk assessment of the proposed FSCA, and

(b)submit to the Secretary of State—

(i)an initial report on the proposed action, and

(ii)the proposed field safety notice setting out the details in paragraph (6).

(2) The initial report must include—

(a)the manufacturer’s name and contact details;

(b)the UK responsible person’s name and contact details (if there is one);

(c)a description of the devices, including any unique device identifiers;

(d)a description of the FSCA and its proposed implementation;

(e)the reason why the FSCA is required and the justification for the manufacturer’s chosen FSCA, based on the conclusions of the risk assessment produced under paragraph (1)(a);

(f)the number of devices placed on the market or put into service in Great Britain and the estimated number of users affected.

(3) After submitting the initial report and proposed notice under paragraph (1), the manufacturer must implement the FSCA as soon as possible and monitor its progress.

(4) A manufacturer may submit an initial report and a copy of the field safety notice after taking the FSCA if the manufacturer believes the FSCA needs to be taken urgently.

(5) When taking an FSCA, the manufacturer must take all reasonable steps to ensure the field safety notice is sent to users of the device.

(6) The field safety notice must—

(a)identify the devices involved and include any unique device identifiers in a searchable format within the notice;

(b)explain the reasons for the FSCA with reference to the risks to any person;

(c)describe all actions to be taken by users in response.

(7) After completing the FSCA, the manufacturer must submit a final report to the Secretary of State setting out the outcome of the action and including evidence to demonstrate its effectiveness.

(8) The manufacturer must provide the Secretary of State with—

(a)the risk assessment produced under paragraph (1)(a), and

(b)updates and evidence of the progress of the FSCA;

upon request and within 3 working days of any such request.

Field safety corrective actions outside Great Britain

44ZK. —(1) A manufacturer of a device placed on the market or put into service in Great Britain must report to the Secretary of State when taking any field safety corrective action (“ FSCA ”) outside Great Britain, if—

(a)the FSCA relates to a device which is of the same model as the device that has been placed on the market or put into service in Great Britain, and

(b)the manufacturer is not taking the same FSCA in Great Britain.

(2) The report must include—

(a)the manufacturer’s name and contact details;

(b)the UK responsible person’s name and contact details (if there is one);

(c)descriptions of the devices, including any unique device identifiers;

(d)the number of devices placed on the market or put into service in Great Britain and the estimated number of users;

(e)a description of the FSCA and the reason why the FSCA is required outside Great Britain;

(f)the reason the same FSCA is not required in Great Britain.

Post-market surveillance report

44ZL. —(1) Subject to paragraph (4), the manufacturer must produce a post-market surveillance report (“ PMSR ”) for the following—

(a)a device placed on the market in accordance with regulation 19B and classified as belonging to class I under Directive 93/42;

(b)a device placed on the market in accordance with regulation 19C and classified as belonging to class I under Regulation (EU) 2017/745;

(c)a device otherwise placed on the market or put into service in accordance with Part 2 and classified as belonging to class I under regulation 7 (classification of general medical devices);

(d)a device placed on the market in accordance with regulation 44ZB and classified as belonging to class A or B under Regulation (EU) 2017/746;

(e)a device otherwise placed on the market or put into service in accordance with Part 4 that is not a device referred to in the lists in Annex II of Directive 98/79.

(2) The PMSR must include—

(a)a summary of the results and conclusions of the analyses of the information collected as a result of the post-market surveillance plan, and

(b)a description of any preventive or corrective action that has been taken by the manufacturer in relation to the device and the reason for doing so.

(3) A PMSR must be—

(a)produced within 3 years of the device being placed on the market or put into service, whichever is sooner, and

(b)updated by the manufacturer at least every 3 years until the end of the PMS period for the device model.

(4) This regulation shall not apply to a relevant device which is a system or procedure pack, unless–

(a)the system or procedure pack incorporates a medical device which does not bear a UKCA marking or a CE marking; or

(b)the chosen combination of medical devices is not compatible in view of their original intended use.

(5) In paragraph (2)(b) the reference to “ any preventive or corrective action ” includes any action taken before the device was placed on the market or put into service if—

(a)for devices with a certificate that was issued by an approved body or notified body before the declaration of conformity was drawn up, the action was taken after that certificate was issued;

(b)for any other devices, the action was taken after the declaration of conformity was drawn up.

Periodic safety update report

44ZM. —(1) Subject to paragraph (4), unless regulation 44ZL (post-market surveillance report) applies to the device, the manufacturer must produce a periodic safety update report (“ PSUR ”) for each device placed on the market or put into service.

(2) The manufacturer may prepare a single PSUR for a category or group of devices if—

(a)the devices are covered by the same clinical evaluation report under Regulation (EU) 2017/745 or performance evaluation report under Regulation (EU) 2017/746, or

(b)the devices are similar devices and the manufacturer considers that the similarity between the devices justifies preparing a single PSUR for those devices.

(3) The PSUR must include—

(a)a summary of the results and conclusions of the analyses of the information collected as a result of the post-market surveillance plan;

(b)a description of any preventive or corrective action that has been taken by the manufacturer in relation to the device and the reason for doing so;

(c)the required risk analysis;

(d)the conclusions of any post-market clinical follow-up required under Part 2 or 3;

(e)the number of—

(i)devices placed on the market in the UK; and

(ii)devices put into service in the UK without being placed on the market;

(f)a description of the characteristics of the population using the device;

(g)an estimate of—

(i)the size of the population using the device in the UK;

(ii)the size of the population using the device outside the UK;

(iii)the usage frequency of the device, where it is practicable to make such an estimate.

(4) This regulation shall not apply to a relevant device which is a system or procedure pack, unless—

(a)the system or procedure pack incorporates a medical device which does not bear a UKCA marking or a CE marking; or

(b)the chosen combination of medical devices is not compatible in view of their original intended use.

(5) In paragraph (3)(b), “ any preventive or corrective action ” includes any action taken before the device was placed on the market or put into service, if that action was taken after an approved body or notified body issued a certificate in respect of the device.

(6) Unless paragraph (7) applies, the manufacturer must—

(a)produce the first PSUR within 1 year of the device being placed on the market or put into service, whichever is sooner, and

(b)update the PSUR at least every year until the end of the PMS period for the device model.

(7) This paragraph applies to—

(a)a device placed on the market in accordance with regulation 19B and classified as belonging to class IIa under Directive 93/42;

(b)a device placed on the market in accordance with regulation 19C and classified as belonging to class IIa under Regulation (EU) 2017/745;

(c)a device otherwise placed on the market or put into service in accordance with Part 2 and classified as belonging to class IIa under regulation 7 (classification of general medical devices).

(8) Where paragraph (7) applies, the manufacturer must—

(a)produce the first PSUR within 2 years of the device being placed on the market or put into service, whichever is sooner, and

(b)update the PSUR at least every 2 years until the end of the PMS period for the device model.

(9) The manufacturer must submit the PSUR and each updated PSUR to the approved body for the device (if there is one).

(10) The approved body must take into account the PSUR and updated PSURs when carrying out its surveillance activities as part of a conformity assessment procedure set out in these Regulations.

(11) In respect of a device listed in paragraph (12), the approved body must, as soon as reasonably practicable following receipt—

(a)review the PSUR and each updated PSUR to determine whether there is any impact on the certification issued for the device, and

(b)issue a report to the manufacturer and the UK responsible person (if there is one), setting out the conclusions of that review.

(12) The devices referred to in paragraph (11) are—

(a)a device placed on the market or put into service in accordance with Part 2 and classified as belonging to class III under regulation 7 (classification of general medical devices);

(b)a device placed on the market or put into service in accordance with Part 2 and considered to be an implantable device under Directive 93/42;

(c)a device placed on the market or put into service in accordance with Part 3;

(d)a device placed on the market or put into service in accordance with Part 4 that is referred to in the lists in Annex II of Directive 98/79.

(13) The approved body must provide a copy of its completed reports under paragraph (11) to the Secretary of State upon request and within 3 working days of the date of any such request.

Trend reporting

44ZN.—(1) The manufacturer must report to the Secretary of State any significant increases in the frequency or severity of incidents involving a device if the manufacturer considers that increase could have a significant adverse impact on the required risk analysis.

(2) A “significant increase” under paragraph (1) is to be determined in comparison to the foreseeable frequency or severity of the incidents and in accordance with the statistical methodology set out in the post-market surveillance plan.

(3) In relation to a device placed on the market or put into service in accordance with Part 4, the manufacturer must also report to the Secretary of State any significant increase in expected erroneous results in comparison to the stated performance of the device in the instructions for use.

(4) The reporting duties in paragraphs (1) and (3) apply throughout the PMS period for the device model.

(5) An initial report under this regulation must include—

(a)the manufacturer’s name and contact details;

(b)the UK responsible person’s name and contact details (if there is one);

(c)a description of the device, including any unique device identifiers;

(d)the number of devices placed on the market or put into service in Great Britain and the estimated number of users affected;

(e)information in relation to the identified trend.

(6) As soon as possible after submitting an initial report, the manufacturer must—

(a)investigate the identified trend and the device or devices concerned, and

(b)submit a final report to the Secretary of State setting out—

(i)the manufacturer’s conclusions into causes of the identified trend;

(ii)a description of any preventive and corrective actions taken or to be taken by the manufacturer in response to the identified trend.

(7) The manufacturer must provide the Secretary of State with updates and documents relevant to the investigation under paragraph (6)(a) upon request and within 3 working days of the date of any such request.

Reports received by the Secretary of State

44ZO.—(1) The Secretary of State must record reports of incidents involving devices.

(2) If the Secretary of State notifies a manufacturer about a reported incident, the manufacturer must consider whether the incident is a serious incident and take action in accordance with this Part.

(3) If the manufacturer of the device considers that the incident is not a serious incident, the manufacturer must provide an explanatory statement to the Secretary of State as soon as possible.

(4) If the Secretary of State notifies the manufacturer that the Secretary of State does not agree with an explanatory statement provided under paragraph (3), the manufacturer must take action in accordance with this Part as if the manufacturer considered the incident to be a serious incident.

Analysis of information received under Part 4A

44ZP.—(1) The Secretary of State must have processes for monitoring the information received under this Part, in order to identify trends, patterns or signals that may reveal new risks or safety concerns.

(2) If the Secretary of State notifies a manufacturer of an identified risk or safety concern, the manufacturer must investigate the risk or safety concern and submit a report to the Secretary of State as soon as possible setting out—

(a)the methods and conclusions of the manufacturer’s investigation, and

(b)any preventive action or corrective action the manufacturer has taken or intends to take.

(3) Paragraph (2) is without prejudice to any other investigation and reporting requirements in this Part.

Retention of post-market surveillance documentation

44ZQ.—(1) The manufacturer and the UK responsible person (if there is one) must retain the documentation drawn up for the purposes of this Part for the period set out in paragraph (2).

(2) The period is the longer of—

(a)the PMS period for the device model, and

(b)15 years in the case of an implantable device, or 10 years in the case of any other device.

Requests for post-market surveillance documentation

44ZR. Where any provision of this Part requires information or documentation to be provided to the Secretary of State within 3 working days of a request, the Secretary of State may extend the time within which the information or documentation is to be provided if the Secretary of State considers it reasonable to do so.F349]

PART V [F350Notified BodiesF350] [F350Approved BodiesF350] , Conformity Assessment Bodies and Marking of Products

[F351Interpretation of Part V

44A. In this Part, “ medical device ” means a device that is a “ relevant device ” for the purposes of Part II, III or IV. F351]

[F352Meaning of approved body and UK notified body

A45.—(1) An approved body is a conformity assessment body which—

(a)has been designated by the Secretary of State pursuant to the procedure set out in regulation 45 (designation etc. of approved bodies); or

(b)immediately before IP completion day was a UK notified body in respect of which the Secretary of State has taken no action under regulation 45(5) to withdraw a designation.

(2) In this regulation—

“UK notified body” means a body which the Secretary of State had before IP completion day notified to the European Commission in accordance with Article 3(7) of Commission Implementing Regulation (EU) 920/2013 or under Article 15 of Directive 98/79.”. F352]

Designation etc. of [F353approved bodiesF353] E33

45. —(1) The Secretary of State may designate for the purposes of [F354 these Regulations F354] any corporate or other body as a body which is to carry out any of the tasks of [F355 an approved body F355] , and, if he so designates a body (referred to in these Regulations as [F356 an “approved body” F356] ), he shall designate the tasks which it is to carry out.

(2) A body may be designated under paragraph (1) as a body which is to carry out tasks of [F357an approved bodyF357] only if—

(a)in so far as it is to be designated as a body which is to carry out tasks included in [F358Part IIIF358] , it is a body in respect of which the criteria for the designation of [F359approved bodies set out in Annex 8 of Directive 90/385F359][F360 , read with Regulation (EU) No 722/2012,F360] are met;

(b)in so far as it is to be designated as a body which is to carry out tasks included in [F361Part IIF361] , it is a body in respect of which the criteria for the designation of [F362approved bodies set out in Annex XI of Directive 93/42F362][F363 , read with [F364 Regulation (EU) No 722/2012F364] ,F363] are met;

(c)in so far as it is to be designated as a body which is to carry out tasks included in [F365Part IVF365] , it is a body in respect of which the criteria for the designation of [F366approved bodies set out in Annex IX of Directive 98/79F366] are met; and

(d)in so far as it needs to be able to fulfil the functions of an importing Party arising out of [F367a mutual recognition agreementF367] , it is able to do so.

(3) The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

(4) The Secretary of State may vary the tasks that [F368an approved bodyF368] may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

(5) The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

(a)the body so requests;

(b)he considers that it is no longer a body in respect of which the applicable criteria for designation set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, [F369both read with Regulation (EU) No 722/2012F369] or Annex IX of Directive 98/79 are met; or

(c)he considers that the body is not capable of fulfilling the functions of an importing Party arising out of [F370a mutual recognition agreementF370] which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

(6) Before—

(a)effecting a variation under paragraph (4); or

(b)restricting or withdrawing a designation under paragraph (5),

otherwise than at [F371the approved body’s requestF371] , the Secretary of State shall give to the [F372approved bodyF372] an opportunity to make representations to him in writing and shall take into account any such representations as are made.

(7) For the purpose of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, [F373both read with Regulation (EU) No 722/2012F373] or Annex IX of Directive 98/79 are met as respects the tasks which the body wants to carry out, or carries out, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of [F374a mutual recognition agreementF374] which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

(a)any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

(b)any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

(8) The Secretary of State may request that [F375an approved bodyF375] supply to him any or all relevant information and documents, including budgetary documents, necessary—

(a)to enable him to verify that the body meets the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, [F376both read with Regulation (EU) No 722/2012F376] , or Annex IX of Directive 98/79; or

(b)for the purposes of deciding whether or not the body is capable of fulfilling the functions of an importing Party arising out of [F377a mutual recognition agreementF377] which it needs to be able to fulfil,

and the body shall supply to him any and all relevant information or documents so requested.

Designation etc. of UK notified bodies E81

45. —(1) The Secretary of State may designate for the purposes of article 11 of Directive 90/385, article 16 of Directive 93/42 or article 15 of Directive 98/79 any corporate or other body as a body which is to carry out any of the tasks of a notified body[F668 with respect to devices to be placed on the market in Northern Ireland F668] , and, if he so designates a body (referred to in these Regulations as a “UK notified body”), he shall designate the tasks which it is to carry out.

(2) A body may be designated under paragraph (1) as a body which is to carry out tasks of a notified body only if—

(a)in so far as it is to be designated as a body which is to carry out tasks included in Directive 90/385, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex 8 of that Directive [F669, read with Regulation (EU) No 722/2012,F669] are met;

(b)in so far as it is to be designated as a body which is to carry out tasks included in Directive 93/42, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex XI of that Directive [F670, read with [F671 Regulation (EU) No 722/2012F671] ,F670] are met;

(c)in so far as it is to be designated as a body which is to carry out tasks included in Directive 98/79, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex IX of that Directive are met; and

(d)in so far as it needs to be able to fulfil the functions of an importing Party arising out of the Mutual Recognition Agreements, it is able to do so.

(3) The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

(4) The Secretary of State may vary the tasks that a UK notified body may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

(5) The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

(a)the body so requests;

(b)he considers that it is no longer a body in respect of which the applicable criteria for designation set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, [F672both read with Regulation (EU) No 722/2012F672] or Annex IX of Directive 98/79 are met; or

(c)he considers that the body is not capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

(6) Before—

(a)effecting a variation under paragraph (4); or

(b)restricting or withdrawing a designation under paragraph (5),

otherwise than at the notified body’s request, the Secretary of State shall give to the notified body an opportunity to make representations to him in writing and shall take into account any such representations as are made.

(7) For the purpose of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, [F673both read with Regulation (EU) No 722/2012F673] or Annex IX of Directive 98/79 are met as respects the tasks which the body wants to carry out, or carries out, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

(a)any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

(b)any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

(8) The Secretary of State may request that a UK notified body supply to him any or all relevant information and documents, including budgetary documents, necessary—

(a)to enable him to verify that the body meets the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, [F674both read with Regulation (EU) No 722/2012F674] , or Annex IX of Directive 98/79; or

(b)for the purposes of deciding whether or not the body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil,

and the body shall supply to him any and all relevant information or documents so requested.

[F378Choice of approved bodies and conformity assessment bodiesF378] E34

46. Where a conformity assessment procedure involves the intervention of [F379an approved bodyF379] , including work which may be carried out by a third country conformity assessment body, the manufacturer of a device or [F380the manufacturer’s UK responsible personF380] may apply to [F381any approved bodyF381] or third country conformity assessment body to carry out tasks under that procedure which are within the framework of tasks which the body is designated to carry out.

Choice of notified bodies and conformity assessment bodies E82

46. Where a conformity assessment procedure involves the intervention of a notified body, including work which may be carried out by a third country conformity assessment body, the manufacturer of a device or his authorised representative may apply to any notified body or third country conformity assessment body to carry out tasks under that procedure which are within the framework of tasks which the body is designated to carry out.

[F382General matters relating to approved bodiesF382] E35

47.—(1)[F383 An approved bodyF383] to which an application has been made by a manufacturer or [F384the manufacturer’s UK responsible personF384] to perform the functions of [F385an approved bodyF385] under a conformity assessment procedure set out in [F386these RegulationsF386] shall perform those functions, in accordance with the requirements of the procedure, if those functions are within the framework of tasks which the body is designated to carry out.

(2) Where a manufacturer or [F387the manufacturer’s UK responsible personF387] has supplied information or data to [F388an approved bodyF388] in the course of a conformity assessment procedure, that body may, where duly justified, require the manufacturer to provide any additional information or data which it considers necessary for the purposes of that procedure.

F391,F392(3) The information, data and correspondence that a manufacturer or [F389the manufacturer’s UK responsible person supplies to an approved bodyF389] in the course of a conformity assessment procedure set out in [F390these RegulationsF390] shall, ..., be in English ....

F394(4)[F393 An approved bodyF393] shall, as respects a medical device which it has assessed ..., inform all [F395other approved bodiesF395] and the Secretary of State of—

(a)all certificates suspended or withdrawn; and

(b)on request, all certificates issued or refused,

and shall also make available to them, on request, any or all additional relevant information.

F394(5) Where [F396an approved bodyF396] finds, as respects a medical device which it has assessed ..., that—

(a)the applicable requirements of [F397these RegulationsF397] have not been met or are no longer met; or

(b)a certificate issued by it should not have been issued,

it may (having regard in particular to the principle of proportionality and the ability of the manufacturer to take appropriate corrective measures) suspend or withdraw the certificate issued in respect of that device or place restrictions on it, and in such cases, or in cases where the [F398approved bodyF398] is aware of circumstances in which the Secretary of State may need to take action pursuant to regulation 61, the [F398approved bodyF398] shall inform the Secretary of State thereof.

(6) The Secretary of State may request that [F399an approved bodyF399] supply to him any information and documents that the Secretary of State may, having regard to the terms of [F400a mutual recognition agreementF400] , need to supply to a Party to [F400a mutual recognition agreementF400] , and the body shall supply to him any and all information or documents so requested.

(8)[F401 An approved bodyF401] shall provide conformity assessment bodies with all the information it is required to provide to those bodies under [F402a mutual recognition agreementF402] .

F403(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F403(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

General matters relating to UK notified bodies E83

47.—(1) A UK notified body to which an application has been made by a manufacturer or his authorised representative to perform the functions of a notified body under a conformity assessment procedure set out in the Medical Devices Directives shall perform those functions, in accordance with the requirements of the procedure, if those functions are within the framework of tasks which the body is designated to carry out.

(2) Where a manufacturer or his authorised representative has supplied information or data to a UK notified body in the course of a conformity assessment procedure, that body may, where duly justified, require the manufacturer to provide any additional information or data which it considers necessary for the purposes of that procedure.

(3) The information, data and correspondence that a manufacturer or his authorised representative supplies to a notified body in the course of a conformity assessment procedure set out in the Medical Devices Directives shall, if the notified body is within the United Kingdom, be in English or some other Community language acceptable to the notified body concerned.

F675(4) A UK notified body shall, as respects a medical device which it has assessed ..., inform all other notified bodies and the Secretary of State of—

(a)all certificates suspended or withdrawn; and

(b)on request, all certificates issued or refused,

and shall also make available to them, on request, any or all additional relevant information.

F675(5) Where a UK notified body finds, as respects a medical device which it has assessed ..., that—

(a)the applicable requirements of the Medical Devices Directives have not been met or are no longer met; or

(b)a certificate issued by it should not have been issued,

it may (having regard in particular to the principle of proportionality and the ability of the manufacturer to take appropriate corrective measures) suspend or withdraw the certificate issued in respect of that device or place restrictions on it, and in such cases, or in cases where the notified body is aware of circumstances in which the Secretary of State may need to take action pursuant to regulation 61, the notified body shall inform the Secretary of State thereof.

(6) The Secretary of State may request that a UK notified body supply to him any information and documents that the Secretary of State may, having regard to the terms of the Mutual Recognition Agreements, need to supply to a Party to the Mutual Recognition Agreements, and the body shall supply to him any and all information or documents so requested.

(8) A UK notified body shall provide conformity assessment bodies with all the information it is required to provide to those bodies under the Mutual Recognition Agreements.

F676(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F676(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F404Register of approved bodies E36

47A.—(1) The Secretary of State must ensure that—

(a)each approved body is assigned an identification number; and

(b)there is a register of—

(i)approved bodies;

(ii)their approved body identification number;

(iii)the tasks for which they have been designated; and

(iv)any restrictions on those tasks.

(2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).F404]

[F677Register of UK notified bodies E84

47A.—(1) The Secretary of State must ensure that—

(a)each notified body established in the United Kingdom is assigned an identification number; and

(b)there is a register of—

(i)notified bodies established in the United Kingdom;

(ii)their notified body identification number;

(iii)the tasks for which they have been notified;

(iv)any restrictions on those tasks.

(2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).F677]

F405 Designation etc. of ... conformity assessment bodies E37

F407 48. —(1) The Secretary of State may designate for the purposes of [F406 a mutual recognition agreement F406] any corporate or other body as a body which is to carry out any of the tasks of a ... conformity assessment body, and, if he so designates a body (referred to in these Regulations as [F408 a “CAB” F408] ), he shall designate the tasks which it is to carry out.

(2) A body may be designated under paragraph (1) as a body which is to carry out tasks of [F409a CABF409] only if the Secretary of State considers that the body is capable of fulfilling the functions of [F409a CABF409] arising out of [F410a mutual recognition agreementF410] which it needs to be able to fulfil.

(3) The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

(4) The Secretary of State may vary the tasks that [F411a CABF411] may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

(5) The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

(a)the body so requests; or

(b)he considers that the body is not capable of fulfilling the functions of [F412a CABF412] arising out of [F413a mutual recognition agreementF413] which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

(6) Before—

(a)effecting a variation under paragraph (4); or

(b)restricting or withdrawing a designation under paragraph (5),

F414,F414otherwise than at the ... CAB’s request, the Secretary of State shall give to the ... CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.

(7) For the purpose of deciding whether or not a body is capable of fulfilling the functions of [F415a CABF415] arising out of [F416a mutual recognition agreementF416] which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

(a)any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

(b)any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

(8) The Secretary of State may request that [F417a CABF417] supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of [F417a CABF417] arising out of [F418a mutual recognition agreementF418] which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.

F678 Designation etc. of ... conformity assessment bodies E85

F680 48. —(1) The Secretary of State may designate for the purposes of [F679 a UK mutual recognition agreement F679] any corporate or other body as a body which is to carry out any of the tasks of a ... conformity assessment body, and, if he so designates a body (referred to in these Regulations as [F681 a “CAB” F681] ), he shall designate the tasks which it is to carry out.

(2) A body may be designated under paragraph (1) as a body which is to carry out tasks of [F682a CABF682] only if the Secretary of State considers that the body is capable of fulfilling the functions of [F682a CABF682] arising out of [F683a UK mutual recognition agreementF683] which it needs to be able to fulfil.

(3) The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

(4) The Secretary of State may vary the tasks that [F684a CABF684] may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

(5) The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

(a)the body so requests; or

(b)he considers that the body is not capable of fulfilling the functions of [F685a CABF685] arising out of [F686a UK mutual recognition agreementF686] which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

(6) Before—

(a)effecting a variation under paragraph (4); or

(b)restricting or withdrawing a designation under paragraph (5),

F687,F687otherwise than at the ... CAB’s request, the Secretary of State shall give to the ... CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.

(7) For the purpose of deciding whether or not a body is capable of fulfilling the functions of [F688a CABF688] arising out of [F689a UK mutual recognition agreementF689] which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

(a)any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

(b)any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

(8) The Secretary of State may request that [F690a CABF690] supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of [F690a CABF690] arising out of [F691a UK mutual recognition agreementF691] which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.

[F419Fees charged by approved bodies and conformity assessment bodiesF419] E38

49.—(1)[F420 An approved body or CABF420] may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with—

[F421 (a)in the case of an approved body, performing the functions of an approved body or an importing Party under these Regulations or a mutual recognition agreement; andF421]

(b)in the case of [F422a CABF422] , performing the functions of [F422a CABF422] arising out of [F423a mutual recognition agreementF423] in respect of a conformity assessment procedure for a medical device.

(2) Except as provided for by paragraph (3), the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.

(3) Where the [F424approved body or CABF424] charging the fee is a body the activities of which are carried on for profit, the fee may include an amount representing a profit which is reasonable in the circumstances, having regard to—

(a)the character and extent of the work done or to be done by the [F425approved bodyF425] ; and

(b)the commercial rate normally charged in respect of profit for that work or similar work.

(4) The [F426approved body or CABF426] may require payment of the fee, or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.

[F692Fees charged by UK notified bodies and conformity assessment bodiesF692] E86

49.—(1) A UK notified body or [F693CABF693] may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with—

(a)in the case of a UK notified body, performing the functions of a notified body or an importing Party under [F694the Medical Devices Directives or a UK mutual recognition agreement in respect of a conformity assessment procedure set out in the Medical Devices Directives or these Regulations as they apply in Great BritainF694] ; and

(b)in the case of [F695a CABF695] , performing the functions of [F695a CABF695] arising out of [F696a UK mutual recognition agreementF696] in respect of a conformity assessment procedure for a medical device.

(2) Except as provided for by paragraph (3), the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.

(3) Where the UK notified body or [F697CABF697] charging the fee is a body the activities of which are carried on for profit, the fee may include an amount representing a profit which is reasonable in the circumstances, having regard to—

(a)the character and extent of the work done or to be done by the notified body; and

(b)the commercial rate normally charged in respect of profit for that work or similar work.

(4) The UK notified body or [F698CABF698] may require payment of the fee, or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.

Products incorrectly marked with [F427an approved bodyF427] or conformity assessment body number E39

50.—(1) No person shall—

(a)affix [F428an approved bodyF428] or conformity assessment body number to a medical device if that body has not carried out an assessment in respect of that device for that person;

(b)supply a medical device (if that supply is also a placing on the market, or if that supply is of a device which has been placed on the market) which has affixed to it [F428an approved bodyF428] or conformity assessment body number if that body—

(i)has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or

(ii)has had its designation as [F428an approved bodyF428] or conformity assessment body withdrawn.

(2) No person shall provide information comprising [F429an approved bodyF429] or conformity assessment body number on a medical device, the instructions for use for a medical device, or the sales packaging for a medical device if that device—

(a)is being or has been placed on the market; and

(b)[F430 the approved bodyF430] or conformity assessment body—

(i)has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or

(ii)has had its designation as [F429an approved bodyF429] or conformity assessment body withdrawn.

(3) Where the sectoral annex on medical devices in a Mutual Recognition Agreement under which a conformity assessment body was designated states that the annex does not apply to devices of a particular class or description, no person may supply a medical device of that class or description bearing the number of that conformity assessment body (if that supply is also a placing on the market or putting into service or is of a device that has been placed on the market or put into service) unless—

(a)an assessment has been carried out on that device for the person responsible for placing it on the market or putting it into service by [F431an approved bodyF431] ; and

(b)the device bears the [F432approved bodyF432] number of that [F432approved bodyF432] .

(4) For the purposes of this regulation, [F433an approved bodyF433] shall be taken to have carried out an assessment in respect of a device if it has endorsed a report prepared by a third country conformity assessment body in respect of that device.

Products incorrectly marked with a notified body or conformity assessment body number E87

50.—(1) No person shall—

(a)affix a notified body or conformity assessment body number to a medical device if that body has not carried out an assessment in respect of that device for that person;

(b)supply a medical device (if that supply is also a placing on the market, or if that supply is of a device which has been placed on the market) which has affixed to it a notified body or conformity assessment body number if that body—

(i)has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or

(ii)has had its designation as a notified body or conformity assessment body withdrawn.

(2) No person shall provide information comprising a notified body or conformity assessment body number on a medical device, the instructions for use for a medical device, or the sales packaging for a medical device if that device—

(a)is being or has been placed on the market; and

(b)the notified body or conformity assessment body—

(i)has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or

(ii)has had its designation as a notified body or conformity assessment body withdrawn.

(3) Where the sectoral annex on medical devices in a Mutual Recognition Agreement under which a conformity assessment body was designated states that the annex does not apply to devices of a particular class or description, no person may supply a medical device of that class or description bearing the number of that conformity assessment body (if that supply is also a placing on the market or putting into service or is of a device that has been placed on the market or put into service) unless—

(a)an assessment has been carried out on that device for the person responsible for placing it on the market or putting it into service by a notified body; and

(b)the device bears the notified body number of that notified body.

(4) For the purposes of this regulation, a notified body shall be taken to have carried out an assessment in respect of a device if it has endorsed a report prepared by a third country conformity assessment body in respect of that device.

Products incorrectly marked with a [F434UK markingF434] E40

51.—(1) No person shall—

(a)affix the [F435UK markingF435] for a medical device to a product which is not a medical device; or

(b)supply a product (if that supply is also a placing on the market, or if that supply is of a product which has been placed on the market) which has affixed to it the [F435UK markingF435] for a medical device if that product is not a medical device.

(2) No person shall provide information comprising a [F435UK markingF435] for a medical device on a product, the instructions for use for a product, or the sales packaging for a product if the product is not a medical device.

Products incorrectly marked with a CE marking E88

51.—(1) No person shall—

(a)affix the CE marking for a medical device to a product which is not a medical device; or

(b)supply a product (if that supply is also a placing on the market, or if that supply is of a product which has been placed on the market) which has affixed to it the CE marking for a medical device if that product is not a medical device.

(2) No person shall provide information comprising a CE marking for a medical device on a product, the instructions for use for a product, or the sales packaging for a product if the product is not a medical device.

PART VI Fees charged by the Secretary of State

Interpretation of Part VI

F43652.—(1) In this Part...—

(2) For the purposes of this Part, medical devices are classified as being implantable or long term invasive medical devices in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42, and in the event of a dispute over the classification of a device, the Secretary of State shall determine the classification of the device in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42.

Fees in connection with the registration of devices and changes to registration details E41

53. Any person required to supply the Secretary of State with any information under [F438regulation 7A, 19, 21A, 33A or 44F438] shall, in respect of the processing of that information with regard to the possible registration of that person by the Secretary of State or possible changes to his registration details, pay to the Secretary of State a fee of [F439£261F439] , and that fee—

(a)shall be payable when the information is supplied by that person to the Secretary of State; and

(b)shall accompany that information when it is supplied.

Fees in connection with the registration of devices and changes to registration details E89

53. Any person required to supply the Secretary of State with any information under regulation 19 [F699, 21BF699] or 44 shall, in respect of the processing of that information with regard to the possible registration of that person by the Secretary of State or possible changes to his registration details, pay to the Secretary of State a fee of [F700£261F700] , and that fee—

(a)shall be payable when the information is supplied by that person to the Secretary of State; and

(b)shall accompany that information when it is supplied.

[F440Fees payable in connection with the designation of approved bodiesF440] E42

54.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 45 as [F441an approved bodyF441] shall, in connection with that application for designation, pay to the Secretary of State—

(a)if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of [F442£10,335F442] ; or

(b)in all other cases, a fee of [F443£41,337F443] .

[F444 (2) A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) must, in connection with that application for a variation, pay to the Secretary of State—

(a)in respect of an extension to the scope of the body’s designation to carry out tasks under Part 2, Part 3 or Part 4, which extends the body’s designation in relation to a Part under which they have already been designated, a fee of [F445 £14,568F445] ;

(b)in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and where the Secretary of State considers that an additional assessment of the body’s procedures is required, a fee of [F446 £21,105F446] .F444]

(3) Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, [F447both read with Regulation (EU) No 722/2012F447] or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of [F448a mutual recognition agreementF448] which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F449 (a)in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of [F450 £67,606F450] plus the amounts specified in paragraph (3A);

[F451 (b)in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection, a fee of [F452 £52,929F452] , plus the amounts specified in paragraph (3A); andF451]

(c)in respect of an inspection pursuant to regulation 45(7)(b), a fee of [F453 £11,672F453] plus the amounts specified in paragraph (3A).F449]

[F454 (3A) Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be—

(a)an amount for time spent by a member of staff undertaking a site visit at a rate—

(i)for the time spent on site, of [F455 £732F455] per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

(ii)for the time spent travelling to and from the site, of [F456 £198F456] per hour;

(b)the actual costs of travel, accommodation and subsistence; and

(c)out of pocket expenses.

(3B) Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—

(a)the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and

(b)the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).F454]

[F457 (3C)[F458 An approved bodyF458] that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—

(a)a fee of [F459 £41,337F459] in respect of the application; and

(b)where an audit is carried out in connection with the application, a fee of [F460 £67,606F460] in respect of the audit [F461 ,

plus the amounts specified in paragraph (3A).F461]

(3D) Where the Secretary of State conducts an assessment of [F462 an approved bodyF462] pursuant to article 5 of Regulation (EU) No 920/2013, [F463 the approved bodyF463] shall pay to the Secretary of State—

(a)if the assessment relates to the dfnUK notified body’s assessment of clinical data only, a fee of [F464 £21,535F464] ; or

(b)in any other case, a fee of [F465 £26,408F465] [F466 ,

plus the amounts specified in paragraph (3A).F466]

(3E)[F467 An approved bodyF467] that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of [F468 £1,503F468] .F457]

[F469 (3F) Where, pursuant to regulation 45(7)(a) or 45(7)(b), the Secretary of State conducts an on-site assessment of a subsidiary of the body, the body must pay to the Secretary of State a fee of [F470 £26,408F470] , plus the costs and expenses referred to in paragraph (3A).F469]

(4) A fee under this regulation—

(a)in connection with an application for designation under [F471regulation 45(1),F471] a variation under regulation 45(4) [F472, a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012F472] —

(i)shall be payable when the application [F473or submissionF473] to the Secretary of State is made, and

(ii)shall accompany the application [F474or submissionF474] when it is made;

(b)in connection with an inspection pursuant to regulation 45(7) [F475or an audit or assessment pursuant to Regulation (EU) No 920/2013F475] , shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

[F476 (5) In this regulation—

“ Regulation (EU) No 920/2013 ” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices; and

“ subsidiary ” is to be construed in accordance with section 1159 of the Companies Act 2006 . F476]

Fees payable in connection with the designation etc. of UK notified bodies E90

54.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 45 as a notified body shall, in connection with that application for designation, pay to the Secretary of State—

(a)if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of [F701£2,063F701] ; or

(b)in all other cases, a fee of [F702£8,252F702] .

(2) A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) of the tasks that the body may carry out shall, in connection with that application for a variation, pay to the Secretary of State a fee of [F703£6,504F703] .

(3) Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, [F704both read with Regulation (EU) No 722/2012F704] or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F705 (a)in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of [F706 £15,904F706] plus the amounts specified in paragraph (3A);

(b)in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection—

(i)if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in all three of the Annexes referred to in this paragraph are met, a fee of [F707 £10,160F707] ,

(ii)if the inspection is for the purpose of deciding whether or not the body is one in respect of which the criteria set out in only two of the three Annexes referred to in this paragraph are met, a fee of [F707 £10,160F707] , or

(iii)if the inspection is for the purposes of deciding whether or not the body is one in respect of which the criteria set out in only one of the Annexes referred to in this paragraph are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, a fee of [F707 £10,160F707] ,

plus the amounts specified in paragraph (3A); and

(c)in respect of an inspection pursuant to regulation 45(7)(b), a fee of [F708 £4,404F708] plus the amounts specified in paragraph (3A).F705]

[F709 (3A) Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be—

(a)an amount for time spent by a member of staff undertaking a site visit at a rate—

(i)for the time spent on site, of [F710 £361.20F710] per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

(ii)for the time spent travelling to and from the site, of [F711 £90.30F711] per hour;

(b)the actual costs of travel, accommodation and subsistence; and

(c)out of pocket expenses.

(3B) Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—

(a)the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and

(b)the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).F709]

[F712 (3C) A UK notified body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—

(a)a fee of £8,252 in respect of the application; and

(b)where an audit is carried out in connection with the application, a fee of £15,904 in respect of the audit.

(3D) Where the Secretary of State conducts an assessment of a UK notified body pursuant to article 5 of Regulation (EU) No 920/2013, the UK notified body shall pay to the Secretary of State—

(a)if the assessment relates to the dfnUK notified body’s assessment of clinical data only, a fee of £2,586; or

(b)in any other case, a fee of £3,876.

(3E) A UK notified body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of £532.F712]

(4) A fee under this regulation—

(a)in connection with an application for designation under [F713regulation 45(1),F713] a variation under regulation 45(4) [F714, a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012F714] —

(i)shall be payable when the application [F715or submissionF715] to the Secretary of State is made, and

(ii)shall accompany the application [F716or submissionF716] when it is made;

(b)in connection with an inspection pursuant to regulation 45(7) [F717or an audit or assessment pursuant to Regulation (EU) No 920/2013F717] , shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

[F718 (5) In this regulation, “Regulation ( EU ) No 920/2013” means Commission Implementing Regulation ( EU ) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices. F718]

F477 Fees payable in connection with the designation etc. of ... conformity assessment bodies E43

55.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 48 as [F478a CABF478] shall, in connection with that application for designation, pay to the Secretary of State—

(a)if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of [F479£10,335F479] ; or

(b)in all other cases, a fee of [F480£41,337F480] .

[F481 (2) A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) must, in connection with that application for a variation, pay to the Secretary of State—

(a)in respect of an extension to the scope of the body’s designation to carry out tasks arising out of a mutual recognition agreement that were not previously within the scope of the body’s designation, a fee of [F482 £14,568F482] ; or

(b)in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and which requires the Secretary of State to undertake an additional assessment of the body’s procedures, a fee of [F483 £21,105F483] .F481]

(3)[F484 Subject to paragraphs (3A) to (3C)F484] where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of [F485a CABF485] arising out of [F486a mutual recognition agreementF486] which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F487 (a)in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of [F488 £67,606F488] plus the amounts specified in paragraph (3D);

(b)in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of [F489 £11,672F489] plus the amounts specified in paragraph (3D);

(c)in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of [F490 £1,880F490] ;

(d)in respect of an inspection pursuant to regulation 48(7)(b), a fee of [F491 £11,672F491] plus the amounts specified in paragraph (3D).F487]

[F492 (3A) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be [F493 £67,606F493] plus—

(a)[F494 £1,880F494] for each additional inspection; and

(b)the amounts specified in paragraph (3D).

(3B) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be [F495 £11,672F495] plus—

(a)[F496 £1,880F496] for each additional inspection; and

(b)the amounts specified in paragraph (3D)

(3C) Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be [F497 £1,880F497] for each inspection.

(3D) The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be—

(a)an amount for time spent by a member of staff undertaking a site visit at a rate—

(i)for the time spent on site, of [F498 £732F498] per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

(ii)for the time spent travelling to and from the site, of [F499 £198F499] per hour;

(b)the actual costs of travel, accommodation and subsistence, and

(c)out of pocket expenses.F492]

(4) A fee under this regulation—

(a)in connection with an application for designation under regulation 48(1) or a variation under regulation 48(4)—

(i)shall be payable when the application to the Secretary of State is made, and

(ii)shall accompany the application when it is made;

(b)in connection with an inspection pursuant to regulation 48(7), shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

F719 Fees payable in connection with the designation etc. of ... conformity assessment bodies E91

55.—(1) A corporate or other body that applies to the Secretary of State for designation under regulation 48 as [F720a CABF720] shall, in connection with that application for designation, pay to the Secretary of State—

(a)if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of [F721£10,335F721] ; or

(b)in all other cases, a fee of [F722£41,337F722] .

[F723 (2) A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) must, in connection with that application for a variation, pay to the Secretary of State—

(a)in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out tasks arising out of a UK mutual recognition agreement that were not previously within the scope of the body’s designation, a fee of [F724 £14,568F724] ; or

(b)in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and which requires the Secretary of State to undertake an additional assessment of the body’s procedures, a fee of [F725 £21,105F725] .F723]

(3)[F726 Subject to paragraphs (3A) to (3C)F726] where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of [F727a CABF727] arising out of [F728a UK mutual recognition agreementF728] which it needs to be able to fulfil, the body shall pay to the Secretary of State—

[F729 (a)in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of [F730 £67,606F730] plus the amounts specified in paragraph (3D);

(b)in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of [F731 £11,672F731] plus the amounts specified in paragraph (3D);

(c)in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of [F732 £1,880F732] ;

(d)in respect of an inspection pursuant to regulation 48(7)(b), a fee of [F733 £11,672F733] plus the amounts specified in paragraph (3D).F729]

[F734 (3A) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be [F735 £67,606F735] plus—

(a)[F736 £1,880F736] for each additional inspection; and

(b)the amounts specified in paragraph (3D).

(3B) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be [F737 £11,672F737] plus—

(a)[F738 £1,880F738] for each additional inspection; and

(b)the amounts specified in paragraph (3D)

(3C) Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be [F739 £1,880F739] for each inspection.

(3D) The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be—

(a)an amount for time spent by a member of staff undertaking a site visit at a rate—

(i)for the time spent on site, of [F740 £732F740] per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

(ii)for the time spent travelling to and from the site, of [F741 £198F741] per hour;

(b)the actual costs of travel, accommodation and subsistence, and

(c)out of pocket expenses.F734]

(4) A fee under this regulation—

(a)in connection with an application for designation under regulation 48(1) or a variation under regulation 48(4)—

(i)shall be payable when the application to the Secretary of State is made, and

(ii)shall accompany the application when it is made;

(b)in connection with an inspection pursuant to regulation 48(7), shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

Fees payable in relation to clinical investigation notices E44

56.—(1) Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—

(a)if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—

(i)a fee, if the device is a Group A device, of [F500£11,701F500] , or

(ii)a fee, if the device is a Group B device, of [F501£22,678F501] ; or

(b)in all other cases—

(i)a fee, if the device is a Group A device, of [F502£15,309F502] , or

(ii)a fee, if the device is a Group B device, of [F503£32,016F503] .

(2) Except where paragraph (3) [F504or (3A)F504] applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or [F505their UK responsible personF505] has previously given such notice in relation to that device.

(3) A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—

(a)a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;

(b)a change to the number of patients or devices forming the basis of the proposed trial;

(c)a change or extension in the indications for use of the device or to the purpose or objectives of the trial;

(d)a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or

(e)a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.

[F506 (3A) Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—

(a)a fee, if the device is a Group A device, of [F507 £226F507] ; or

(b)a fee, if the device is a Group B device, of [F508 £361F508] .F506]

[F509 (3B) A person who requests a meeting with the Secretary of State in respect of an intended clinical investigation under regulation 16(1A) or 29(1A) must pay the following fees in advance of the meeting—

(a)[F510 £987F510] for a regulatory advice meeting under regulation 16(1A)(a) or 29(1A)(a); and

(b)[F511 £852F511] for a statistical review meeting under regulation 16(1A)(b) or 29(1A)(b).F509]

(4) A fee under this regulation—

(a)shall be payable when the notice to which it relates is given to the Secretary of State; and

(b)shall accompany that notice when it is given.

Fees payable in relation to clinical investigation notices E92

56.—(1) Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—

(a)if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—

(i)a fee, if the device is a Group A device, of [F742£2,920F742] , or

(ii)a fee, if the device is a Group B device, of [F742£3,570F742] ; or

(b)in all other cases—

(i)a fee, if the device is a Group A device, of [F743£3,820F743] , or

(ii)a fee, if the device is a Group B device, of [F743£5,040F743] .

(2) Except where paragraph (3) [F744or (3A)F744] applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or his authorised representative has previously given such notice in relation to that device.

(3) A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—

(a)a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;

(b)a change to the number of patients or devices forming the basis of the proposed trial;

(c)a change or extension in the indications for use of the device or to the purpose or objectives of the trial;

(d)a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or

(e)a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.

[F745 (3A) Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—

(a)a fee, if the device is a Group A device, of £207; or

(b)a fee, if the device is a Group B device, of £331.F745]

(4) A fee under this regulation—

(a)shall be payable when the notice to which it relates is given to the Secretary of State; and

(b)shall accompany that notice when it is given.

[F512Fees in connection with approval of coronavirus test devices

56A.—(1) A person who makes an application to the Secretary of State under regulation 38A(1) must pay to the Secretary of State a fee of—

(a)£14,000; or

(b)if the person is a small or medium-sized enterprise, £6,200.

(2) Where the Secretary of State, in accordance with regulation 38A(4), treats an application made before the coming into force of regulation 38A as an application made under that regulation, a payment made in respect of that application before the coming into force of this regulation must be treated as—

(a)a payment meeting the requirements of paragraph (1), if that payment would have met those requirements after their coming into force; or

(b)a payment contributing in part to the payment required by paragraph (1), if that payment would not have met those requirements after their coming into force.

(3) In this regulation—

(a)a person is a small or medium-sized enterprise if it and persons associated with it employ no more than 250 individuals in total; and

(b) “persons associated with it” has the same meaning as in section 882 of the Corporation Tax Act 2010 . F512]

[F513Circumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device

56B.—(1) Subject to paragraph (2), the fee payable by an approved body in respect of a consultation or further consultation with the Secretary of State in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device is the fee specified in regulation 56C.

(2) No fee is payable if it is the first time the Secretary of State has been consulted by any approved body in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device if the medicinal substance is an authorised medicinal product.F513]

[F514Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device

56C.—(1) Subject to regulation 56B(2) and paragraph (3), the fee in respect of a consultation in relation to a device which incorporates one or more medicinal substances is—

(a)[F515 £4,953F515] if each medicinal substance is manufactured by an approved manufacturer of that substance;

(b)[F516 £11,543F516] if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

(2) Subject to paragraph (3), the fee in respect of a further consultation in relation to a device which incorporates one or more medicinal substances is—

(a)[F517 £980F517] if each medicinal substance is manufactured by an approved manufacturer of that substance;

(b)[F518 £2,668F518] if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

(3) In relation to a device which incorporates a new medicinal substance, the fee is—

(a)[F519 £50,644F519] for a consultation; and

(b)[F520 £12,574F520] for a further consultation.

(4) Where an approved body consults the Secretary of State in relation to more than one device at the same time and those devices—

(a)are of similar construction and are designed to perform similar functions;

(b)incorporate medicinal substances of the same specification which are manufactured by the same manufacturer or manufacturers; and

(c)do not incorporate any other medicinal substance;

the fee payable for that consultation is the fee which would be payable under this regulation for a consultation in relation to one of those devices.

(5) Any fee payable under this regulation must be paid to the Secretary of State not later than the day on which an approved body consults the Secretary of State.F514]

Fees payable in connection with pre-consultation meetings

F52156D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F522Fees payable in connection with regulatory advice meetings

56E.—(1) Unless regulation 56(3B)(a) applies, or regulation 17A(2)(a) of the Medical Devices (Northern Ireland Protocol) Regulations 2021 applies, the fee payable by a person with whom the Secretary of State holds a meeting in order to provide regulatory advice relating to a medical device is £987 for each hour that meeting takes.

(2) Any fee payable under this regulation must be paid within 14 days following written notice from the Secretary of State requiring payment of that fee.F522]

Unpaid fees

57. All unpaid sums due by way of, or on account of, any fees payable under this Part are recoverable as debts due to the Crown.

Waivers, reductions and refunds

58.—(1) The Secretary of State may—

(a)waive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;

(b)refund the whole or part of any fee paid pursuant to this Part.

(2) Without prejudice to the generality of paragraph (1), where—

(a)a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; or

(b)an application for designation as—

(i)[F523 an approved bodyF523] under regulation 45(1), or

(ii)[F524 a CABF524] under regulation 48(1),

(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,

the fee payable shall be reduced to fifty per cent of the fee otherwise payable in respect of such notice or application, and any excess already paid shall be refunded.

Waivers, reductions and refunds

58.—(1) The Secretary of State may—

(a)waive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;

(b)refund the whole or part of any fee paid pursuant to this Part.

(2) Without prejudice to the generality of paragraph (1), where—

(a)a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; or

(b)an application for designation as—

(i)a notified body under regulation 45(1), or

(ii)[F746 a CABF746] under regulation 48(1),

(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,

the fee payable shall be reduced to fifty per cent of the fee otherwise payable in respect of such notice or application, and any excess already paid shall be refunded.

[F525Time for payment of fees - small companies

58A.—(1) Where a fee in regulation 56(1) is payable by a small company, if the small company so requests to the Secretary of State in writing, 50% of that fee shall be payable when the notice to which it relates is given to the Secretary of State and 50% of that fee shall be payable within six months of the date when the notice is given.

(2) For the purpose of this regulation, a company is a small company if, for the financial year before that in which the notice is given, the total value of products it has sold or supplied for the financial year is not more than the amount specified in item 1 in section 382(3) (qualification of company as small) of the Companies Act 2006 and either—

(a)the company’s balance sheet total as defined in section 382(5) of the Companies Act 2006 is not more than the amount specified in item 2 in section 382(3) of that Act; or

(b)the average number of persons employed by the company in the financial year before that in which the notice is given (determined on a weekly basis) does not exceed the number specified in item 3 in section 382(3) of that Act.

(3) In this regulation, a reference to section 382 of the Companies Act 2006 is a reference to that section as amended by the Companies (Accounts and Reports) (Amendment and Transitional Provision) Regulations 2024.F525]

PART VII General, Enforcement and Miscellaneous

Interpretation of Part VII

F52659. In this Part ...—

[F529Status of UK responsible personF529] E45

F53060.—(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F530(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F531 (3) A UK responsible person—

(a)may be proceeded against as a person placing the device on the market for the purposes of these regulations;

(b)in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.F531]

(4) If a person claims or purports to act as [F532a UK responsible personF532] , the Secretary of State may, for the purposes of enabling the Secretary of State to exercise his functions under these Regulations, require that person to furnish the Secretary of State with sufficient [F533evidence that he is [F534 a UK responsible personF534,F533]] .

Designation etc. of authorised representatives E93

F74760.—(1) Where these Regulations place any obligation... on a manufacturer of a device or his authorised representative, and the manufacturer does not have a registered place of business[F748 in a relevant stateF748] , no person shall—

(a)place that device on the market; or

(b)supply that device in circumstances where it has been placed on the market,

unless the manufacturer of the device has designated [F749a single authorised representativeF749] to perform that obligation, but once the manufacturer has designated [F749a single authorised representativeF749] to perform that obligation, that obligation shall be performed by the authorised representative (although in all other cases it shall be performed by the manufacturer).

(2) If the manufacturer of a registrable device does not have a registered place of business[F750 in a relevant stateF750] , no person shall place that device on the market or supply that device in circumstances where it has been placed on the market unless its manufacturer has designated [F749a single authorised representativeF749] as—

(a)the person responsible for marketing the device [F751in a relevant stateF751] ; and

(b)the person responsible for registering in respect of that device with—

(i)the Secretary of State in accordance with regulation 19 or, as the case may be, 44, or

(ii)the competent authorities of another Member State or (where appropriate) a State which is a Party to an Association Agreement.

(3) Where a manufacturer of a registrable device, or of a relevant device that is not registrable, has designated [F749a single authorised representativeF749] as the person responsible for marketing the device within [F752a relevant stateF752] , that authorised representative—

(a)may be proceeded against as a person placing the device on the market for the purposes of these Regulations;

(b)in relation to any supply of the device to a person within [F753Northern IrelandF753] after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market, unless that supply is due to an act of another person established in [F754a relevant stateF754] .

(4) If a person claims or purports to act as an authorised representative of a manufacturer of a device, the Secretary of State may, for the purposes of enabling the Secretary of State to exercise his functions under these Regulations, require that person to furnish the Secretary of State with sufficient [F755evidence that he is the single authorised representative of the manufacturerF755] .

Enforcement etc.

[F535 61.—(1A) It is the duty of the Secretary of State to enforce these regulations in relation to relevant devices and devices for performance evaluation.

(1B) It is the duty of each weights and measures authority in Great Britain and each district council in Northern Ireland to enforce these regulations within its area (concurrently with the Secretary of State) in relation to relevant devices that are ordinarily intended for private use or consumption.

(1C) Nothing in this regulation authorises a weights and measures authority to bring proceedings in Scotland for an offence.F535]

Enforcement etc. E94

F756,F757,M1961.—(1) Notwithstanding that they are made partly in exercise of powers other than those conferred by section 11 of the 1987 Act, these Regulations shall be regarded for all purposes relating to enforcement (whether by criminal proceedings, notices or otherwise) ... as safety regulations as defined in that Act , and any provision of these Regulations made under those other powers shall be regarded for those purposes as a safety provision as defined in that Act .

[F758 (1A) Paragraph (1) applies in relation to regulations 10A, 24A and 36A (UK(NI) indication) as it does in relation to any other provision of these Regulations to which it applies.F758]

F759(2) Except as provided by paragraph (3), ... each district council in Northern Ireland is relieved of its duty imposed by section 27(1) of the 1987 Act in so far as it is exercisable in relation to relevant devices or devices for performance evaluation, and that duty is transferred to the Secretary of State.

F760,F761(3) Paragraph (2) does not relieve an authority or council of its duty in relation to devices which are consumer goods..., and accordingly but subject to paragraph (4), ... each district council in Northern Ireland shall, concurrently with the Secretary of State, enforce these Regulations in relation to such devices.

(4) The powers of an enforcement authority to serve restriction notices under regulation 63 are only exercisable by the Secretary of State.

F762(5) Each ... council referred to in paragraph (3) on whom a duty is imposed by section 27(1) of the 1987 Act to enforce the provisions of these Regulations shall give immediate notice to the Secretary of State of—

(a)any suspension notice served by it under section 14 of the 1987 Act in respect of a device to which paragraph (3) applies;

(b)any application made by it under section 16 of the 1987 Act for an order for forfeiture of any such device; and

(c)any other thing done by it in respect of such a device for the purposes of, or in connection with the operation of, sections 14 to 17 of the 1987 Act.

[F763 (6) In respect of an offence committed under section 12 of the 1987 Act relating to a contravention of these Regulations—

F764(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)a magistrates’ court in Northern Ireland may hear and determine any complaint made—

(i)if the offence was committed before 10th March 2007, within 12 months from the time when the offence is committed, or

(ii)if the offence was committed on or after 10th March 2007, within three years from the time when the offence was committed or within one year from the discovery of the offence by the prosecutor, whichever is the earlier; and

F765(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .F763]

(7) The powers conferred by section 13 of the 1987 Act to serve prohibition notices and notices to warn are exercisable in relation to non—conforming devices as they are exercisable in relation to relevant goods which the Secretary of State considers are unsafe (as well as being exercisable in relation to goods considered unsafe by the Secretary of State), and in relation to non-conforming devices, Schedule 2 to the 1987 Act shall have effect as if references to goods being unsafe or safe were references to relevant devices being or not being non-conforming devices.

[F766 (7A) In paragraph (3), “consumer goods” means any goods which are ordinarily intended for private use or consumption. F766]

(8) In paragraph (7), “non-conforming devices” means—

(a)relevant devices which, whether or not the Secretary of State considers them unsafe, are devices with or that require a CE marking which he considers to be devices—

(i)which do not conform as respects a relevant essential requirement[F767 or a requirement of Regulation (EU) No 722/2012 (if applicable)F767] ; or

(ii)to which a CE marking has or should have been applied following a conformity assessment procedure set out in the Medical Devices Directives, and—

(aa)the manufacturer or his authorised representative has failed to comply with his obligations under that procedure, or

(bb)they do not conform to the design or type described in any certificate granted as a result of that procedure; or

(b)devices for performance evaluation which, whether or not the Secretary of State considers them unsafe, are devices in respect of which there is a failure to comply with these Regulations.

Compliance notices

F53662. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Restriction notices

F53763. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Notification of decisions etc.

F53864. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F539 Centralised systems of records etc.

65. The Secretary of State shall perform, as respects [F540 Northern IrelandF540] , the functions of the Member State under article 8 of Directive 90/385, article 10 of Directive 93/42 and article 11(1) to (3) of Directive 98/79.F539]

Revocations

66. The following provisions are hereby revoked—

(a)M7the Active Implantable Medical Devices Regulations 1992 ;

(b)M8the Medical Devices Regulations 1994 ;

(c)M9the Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995 ;

(d)M10the Medical Devices Fees Regulations 1995 ;

(e)M11the Medical Devices Fees (Amendment) Regulations 1997 ;

(f)M12theIn Vitro Diagnostic Medical Devices Regulations 2000 ; and

(g)M13regulations 6 and 13 of the Medicines (Codification Amendments Etc.) Regulations 2002 .

[F541Review E46

67. Before the end of 31st December [F542 2025F542] , the Secretary of State must—

(a)carry out a review of these Regulations;

(b)set out the conclusions of the review in a report; and

(c)publish the report.F541]

[F768Review E95

67. Before the end of 31st December 2019, the Secretary of State must—

(a)carry out a review of these Regulations;

(b)set out the conclusions of the review in a report; and

(c)publish the report.F768]

Signed by authority of the Secretary of State for Health

Hunt

Parliamentary Under Secretary of State,

Department of Health

We consent,

Tony McNulty

Nick Ainger

Two of the Lords Commissioners of Her Majesty’s Treasury

Regulation 2(1)

[F543SCHEDULE 1 ASSOCIATION AGREEMENTS

[F544 1. The Agreement establishing an Association between the European Economic Community and Turkey signed at Ankara on 12th September 1963.F544,F543]]

Regulation 2(1)

SCHEDULE 2 MUTUAL RECOGNITION AGREEMENTS E47

M141. The agreement on mutual recognition in relation to conformity assessment certificates and markings between the European Community and Australia, initialled on 19th July 1996 .

M152. The agreement on mutual recognition in relation to conformity assessment between the European Union and New Zealand, initialled on 19th July 1996 .

M163. The agreement on mutual recognition between the European Community and Canada, signed in London on 14th May 1998 .

M174. The agreement on mutual recognition between the European Community and the United States of America, signed in London on 18th May 1998 .

[F545 5. The agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment signed in Luxembourg on 21st June 1999.F545]

Regulation 1A

[F546SCHEDULE 2 Mutual Recognition Agreement countries E48

Regulation 1A

[F547SCHEDULE 2A Modification of Annexes to Directives 90/385, 93/42, 98/79

PART 1 Modification of Annexes to Directive 90/385

1.—(1) The Annexes to Directive 90/385 are modified so that they read as if amended by paragraphs 2 to 10.

(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002 .

2. In Annex 1—

[F548 (za) in Section 2, for “the functions referred to in Article 1(2)(a)” substitute “the purposes referred to in the definition of a medical device in regulation 2(1) of the Regulations F548]

(a) in Section 8 for the fifth indent substitute —

“–risks connected with ionising radiation from radioactive substances included in the device,”;

(b) for Section 10 substitute—

“10. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in regulation 2 of the Human Medicines Regulations 2012, and which is liable to act upon the body with an action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC as modified by Schedule 8B to the Human Medicines Regulations 2012.

For the substances referred to in the first paragraph, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing an opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.

Where a device incorporates, as an integral part, a human blood derivative, the approved body shall, having verified the usefulness of the substance as part of the device and taking into account the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing the opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.

Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the approved body shall be informed of the changes and shall consult the Secretary of State, in order to confirm that the quality and safety of the ancillary substance are maintained. The Secretary of State shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the approved body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.

When the Secretary of State has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, the Secretary of State shall provide the approved body with advice on whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not. The approved body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.”;

(c) in Section 14.2 —

(i) for “the name and address of the authorised representative” substitute “, where such a person is appointed under regulation 21A of the Regulations, the name and address of the UK responsible person,”;

(ii) for “the Community” substitute “the United Kingdom”;

[F549 (iii) for “a device within the meaning of Article 1(4a)” substitute “a stable derivatives device F549]

(d) in Section 15 in the first indent for “CE mark” substitute “UK mark”.

3. In Annex 2—

(a) for the heading substitute “Declaration of conformity”;

(b) for “the notified body” each time it occurs substitute “the approved body”;

(c) for “this Directive” each time it occurs substitute “the Regulations”;

(d) in Section 1, for “EC Surveillance” substitute “Surveillance”;

(e) in Section 2—

(i) for “his authorized representative” substitute “their UK responsible person”;

(ii) omit “established within the Community”;

(iii) for “CE marking” [F550 , in both places it occurs, F550] substitute “UK marking”;

[F551 (iv) for “Article 12” substitute “regulation 24”; F551]

(f) in Section 3.1—

(i) in the opening words, for “a notified body” substitute “an approved body”;

[F552 (ii) omit the fifth indent;F552]

[F553 (g) in Section 3.2—

(i) in the first paragraph, omit “of this Directive”;

(ii) in point (c), for “Article 5” substitute “regulation 3A of the Regulations”; F553]

[F554 (h) in Section 3.3—

(i) for the first sentence substitute—

“The quality system shall be audited by an approved body to determine whether it meets the requirements referred to in Section 3.2.”

(ii) in the second sentence for “harmonized” substitute “designated”; F554]

(i) in Section 3.4, in the second paragraph, for the first sentence substitute—

“The proposed modifications shall be evaluated by the approved body so as to verify whether the quality system so modified would still meet the requirements referred to in Section 3.2.”;

(j) in Section 4.2 in the second indent for “Article 5” substitute “regulation 3A of the Regulations”;

(k) for Section 4.3 substitute—

“4.3. The approved body must examine the application and, where the product complies with the relevant provisions of the Regulations, shall issue the applicant with a design certificate. The approved body may require the application to be supplemented by further tests or proof so that compliance with the requirements of the Regulations may be evaluated. The certificate shall contain conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.

In the case of devices referred to in Annex 1, Section 10, second paragraph, the approved body shall, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.

In the case of devices referred to in Annex I, Section 10, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.”;

(l) in Section 4.4, for each reference to “EC design” substitute “design”;

(m) in Section 6.1—

(i) for “national authorities” substitute “Secretary of State”;

(ii) for “his authorised representative” substitute “their UK responsible person”;

(n) for Section 6.2 substitute—

“6.2. On request, an approved body must make available to other approved bodies and to the Secretary of State all relevant information on approvals of quality systems, issued, refused or withdrawn.”;

(o) for Section 7 substitute—

“7. Application to the devices incorporating a human blood derivative:

Upon completing the manufacture of each batch of devices incorporating a human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

4. In Annex 3—

(a) in the title for “EC TYPE-EXAMINATION” substitute “TYPE-EXAMINATION”;

(b) for “EC type-examination” in each other place substitute “type-examination”;

(c) for “a notified body” in each place substitute “an approved body”;

(d) for “the notified body” in each place substitute “the approved body”;

(e) in Section 1, for “this Directive” substitute “the Regulations”;

(f) in Section 2—

(i) for the first sentence substitute—

“The application for type-examination shall be made by the manufacturer to the approved body.”;

(ii) for “the authorized representative” substitute “the UK responsible person”;

(iii) for “this Directive” substitute “the Regulations”;

(g) in Section 3, for each reference to “Article 5” substitute “regulation 3A of the Regulations”;

(h) for Sections 4 and 5, substitute—

“4. The approved body shall—

4.1. examine and evaluate the documentation, verify that the type has been manufactured in accordance with that documentation; it shall also record the items which have been designed in accordance with the applicable provisions of the standards referred to in regulation 3A of the Regulations, as well as the items for which the design is not based on the relevant provisions of the said standards.

4.2. carry out or have carried out the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements where the standards referred to in regulation 3A of the Regulations have not been applied.

4.3. carry out or have carried out the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied.

4.4. agree with the applicant on the place where the necessary inspections and tests will be carried out.

5. Where the type meets the provisions of the Regulations, the approved body shall issue a type-examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, the conclusions of the control, the conditions under which the certificate is valid and the information necessary for identification of the type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the approved body.

In the case of devices referred to in Annex I, Section 10, second paragraph, the approved body shall, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.

In the case of devices referred to in Annex I, Section 10, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State shall be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.”;

(i) in Section 6 omit “EC” each time it occurs;

(j) for Section 7 substitute—

“7.1. On request, an approved body shall make available to other conformity assessment bodies (including other approved bodies) and to the Secretary of State all relevant information on type-examination certificates and addenda to those certificates issued, refused and withdrawn.

7.2. The approved body must cooperate with other approved bodies with regard to making available copies of the type examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.

7.3. The manufacturer or their UK responsible person shall keep with the technical documentation a copy of the UK type-examination certificates and the supplements to them for a period of at least 15 years from the manufacture of the last product.”.

5. For Annex 4 substitute—

“ANNEX 4 VERIFICATION

1. Verification is the procedure whereby the manufacturer ensures and declares that the products subject to the provisions of Section 3 are in conformity with the type as described in the type-examination certification and satisfy the requirements of the Regulations that apply to them.

2. The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of the products to the type as described in the type-examination certification and to the requirements of the Regulations that apply to them. The manufacturer shall affix the UK marking to each product and draw up a written declaration of conformity.

3. The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular as regards sterilization, together with all the routine, pre-established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the type examination certificate as well as with the relevant requirements of the Regulations.

F5554. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. The approved body must carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of the Regulations by examination and testing of products on a statistical basis, as specified in Section 6. The manufacturer must authorize the approved body to evaluate the efficiency of the measures taken pursuant to Section 3, by audit where appropriate.

6. Statistical verification

6.1. Manufacturers must present the products manufactured in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.

6.2. A random sample must be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standards referred to in regulation 3A of the Regulations, or equivalent tests must be carried out to verify their conformity to the type as described in the type-examination certificate and thereby determine whether a batch is to be accepted or rejected.

6.3. Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the designated standards referred to in regulation 3A of the Regulations, taking account of the specific nature of the product categories in question.

6.4. Where batches are accepted, the approved body shall affix, or cause to be affixed, its identification number to each product and draw up a written certificate of conformity relating to the tests carried out. All products in the batch may be placed on the market except for those products from the sample which were found not to be in conformity. Where a batch is rejected, the approved body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches the approved body may suspend the statistical verification.

The manufacturer may, with the agreement of the approved body, affix the approved body’s identification number during the manufacturing process.

6.5. The manufacturer or their UK responsible person must ensure that they are able to supply the approved body’s certificates of conformity on request.

7. Application to the devices incorporating human blood derivative:

Upon completing the manufacture of each batch of devices incorporating human blood derivative the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

6. For Annex 5, substitute—

“ANNEX 5 DECLARATION OF CONFORMITY TO TYPE

(Assurance of production quality)

1. The manufacturer shall apply the quality system approved for the manufacture and must conduct the final inspection of the products concerned as specified in Section 3; the manufacturer shall be subject to the surveillance referred to in Section 4.

2. This declaration of conformity is the procedural element whereby the manufacturer who satisfies the obligations of Section 1 guarantees and declares that the products concerned conform to the type described in the type-examination certificate and meet the provisions of the Regulations which apply to them.

The manufacturer must affix the UK marking in accordance with regulation 24 of the Regulations and draw up a written declaration of conformity. This declaration shall cover one or more devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer. The UK marking shall be accompanied by the identification number of the approved body responsible.

3. Quality system

3.1. The manufacturer shall make an application for evaluation of their quality system to an approved body.

The application shall include:

3.2. Application of the quality system must ensure that the products conform to the type described in the type-examination certificate.

All the elements, requirements and provisions adopted by the manufacturer for their quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records. It shall include in particular an adequate description of—

(a)the manufacturer’s quality objectives;

(b)the organization of the business and in particular—

(c)the techniques of control and of quality assurance at the manufacturing stage and in particular—

(d)the appropriate tests and trials which will be effected before, during and after production, the frequency with which they will take place, and the test equipment used.

3.3. Without prejudice to regulation 50 of the Regulations, the approved body shall effect an audit of the quality system to determine whether it meets the requirements referred to in Section 3.2. It shall presume conformity with these requirements for the quality systems which use the corresponding harmonized standards.

The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of the technology concerned. The evaluation procedure shall include an inspection on the manufacturer’s premises.

The decision shall be notified to the manufacturer after the final inspection. It shall contain the conclusions of the control and a reasoned evaluation.

3.4. The manufacturer shall inform the approved body which has approved the quality system of any plan to alter that system.

The approved body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in Section 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the control and a reasoned evaluation.

4. Surveillance

4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations which arise from the approved quality system.

4.2. The manufacturer shall authorize the approved body to carry out all necessary inspections and shall supply it with all appropriate information, in particular—

4.3. The approved body must periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report.

4.4. In addition, the approved body may make unannounced visits to the manufacturer, and must supply the manufacturer with an inspection report.

5. The approved body shall communicate to the other approved bodies all relevant information concerning approvals of quality systems issued, refused or withdrawn.

6. Application to the devices incorporating human blood derivative:

Upon completing the manufacture of each batch of devices, incorporating human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

7. In Annex 6—

(a) in Section 1, for “authorised representative established within the Community” substitute “UK responsible person”;

(b) in Section 3 for “the competent national authorities” substitute “the Secretary of State”;

(c) in Section 3.1 for “this Directive” substitute “the Regulations”;

(d) in Section 3.2 for the fourth indent substitute—

“–the results of the risk analysis and a list of the designated standards provided for in regulation 3A of the Regulations, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements where the standards in regulation 3A of the Regulations have not been applied,”;

[F557 (e) omit Section 5.F557]

[F558 8. In Annex 7—

(a) in Section 1.1 for “harmonised” substitute “designated”;

(b) in Section 2.3.5 for “all competent authorities of the Member States in which the clinical investigation is being performed” substitute “the Secretary of State”; F558]

9. In Annex 8—

(a) in the title for “when designating inspection bodies to be notified” substitute “when designating approved bodies”;

[F559 (aa) in Section 1 for “authorized representative” substitute “UK responsible person”; F559]

(b) in Section 3 omit the words “and for which it has been notified”;

(c) in Section 6 omit from “unless liability” to the end;

(d) in Section 7 omit from “(except vis-à-vis” to the end.

10. Omit Annex 9.

PART 2 Modification of Annexes to Directive 93/42

11.—(1) The Annexes to Directive 93/42 are modified so that they read as if amended by paragraphs 12 to 23.

(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002 .

12. In Annex I—

(a) in Section 3, for “Article 1(2)(a)” substitute “regulation 2(1) of the Regulations”;

(b) in Section 7, for “notified body” each time it occurs substitute “approved body”;

(c) for Section 7.4, substitute—

“7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in regulation 2 of the Human Medicines Regulations 2012, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC as modified by the Human Medicines Regulations 2012.

For the substances referred to in the first paragraph, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing an opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.

Where a device incorporates, as an integral part, a human blood derivative, the approved body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the Secretary of State on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing the opinion, the Secretary of State shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the approved body.

Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the approved body must be informed of the changes and must consult the Secretary of State in order to confirm that the quality and safety of the ancillary substance are maintained. The Secretary of State must take account of the data related to the usefulness of incorporation of the substance into the device as determined by the approved body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.

When the Secretary of State has obtained information on an ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, the Secretary of State must provide the approved body with advice on whether this information has any impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The approved body must take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.”;

(d) in Section 7.5—

(i) for the reference to “Annex 1 to Council Directive 67/548/EEC of 27 June 1967”, substitute “Regulation (EC) No. 1272/2008 ”;

(ii) for the reference to “Annex 1 to Council Directive 67/548/EEC ”, substitute “the UK mandatory classification and labelling list established and maintained in accordance with Article 38A of Regulation 1272/2008”;

(e) in Section 10.3 for “the provisions of Council Directive 80/181/EEC ” substitute “ the Units of Measurement Regulations 1986 ”;

(f) in Section 13.3—

(i) in point (a) —

(aa) for the first two references to “the Community” substitute “Great Britain”;

(bb) for the third reference to “the Community” substitute “the United Kingdom”;

(cc) for “the authorised representative” substitute “the UK responsible person (where appointed in accordance with regulation 7A of the Regulations)”;

(ii) in point (f) omit the second sentence;

(iii) in point (n) omit “in the case of a device within the meaning of Article 1(4a),”.

13. In Annex II—

(a) in the title omit “EC”;

(b) for each reference to “the notified body” substitute “the approved body”;

(c) in Section 1 omit “Community”;

(d) in Section 2—

(i) omit “EC”;

(ii) for “this Directive” substitute “the Regulations”;

(iii) for “CE marking” substitute “UK marking”;

(iv) omit the words “in accordance with Article 17”;

[F560 (da) in Section 3.1—

(i) in the first sentence, for “a notified body” substitute “an approved body”;

(ii) for “other notified body” substitute “other approved body”;

F561 (iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F562 (iv) omit the seventh indent;F562,F560]]

(e) in Section 3.2—

(i) in the first paragraph for “this Directive” substitute “the Regulations”

(ii) in point (c)—

(aa) for “Article 5” substitute “regulation 3A of the Regulations”;

(bb) for “Commission Directive 2003/32/EC ” substitute “Commission Regulation 722/2012”;

(f) for Section 3.3 substitute—

“3.3. The approved body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant designated standards conform to these requirements.

The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product concerned, an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes.

The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.”.

(g) for Section 3.4 substitute—

“3.4. The manufacturer must inform the approved body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The approved body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.”;

(h) in Section 4.2, for “this Directive” substitute “the Regulations”;

(i) for Section 4.3 substitute—

“4.3. The approved body must examine the application and, where the product complies with the relevant provisions of the Regulations, must issue the applicant with a design certificate. The approved body may require the application to be supplemented by further tests or proof so that compliance with the requirement of the Regulations may be evaluated. The certificate must contain conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product.

In the case of devices referred to in Annex 1, Section 7.4, second paragraph, the approved body must, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.

In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.”;

(j) in Section 4.4, omit each reference to “EC”;

(k) in Section 6.1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “national authorities” substitute “Secretary of State”;

(l) in Section 7.1 for “Article 11(2) and (3)” substitute “regulation 13(2) and (3) of the Regulations”;

(m) in Section 7.2 omit “for compliance with the provisions of this Directive”;

(n) in Section 7.3 omit “for compliance with the provisions of this Directive”;

(o) in Section 7.4 —

(i) for “this Directive” substitute “the Regulations”;

(ii) for “the competent authority” substitute “the Secretary of State”;

(p) for Section 8, substitute—

“8. Application to the devices incorporating a human blood derivative

Upon completing the manufacture of each batch of devices incorporating a human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

14. In Annex III—

(a) for each reference to “EC type-examination” (including in the title), substitute “type-examination”;

(b) in Section 1—

(i) for “a notified body” substitute “an approved body”;

(ii) for “this Directive” substitute “the Regulations”;

(c) in Section 2—

(i) in the first indent,—

(aa) for “authorized representative” substitute “UK responsible person” ;

(bb) for “the representative” substitute “the UK responsible person”;

(ii) in the second indent, for the second and third sentences substitute—

“The applicant must provide samples at the request of the approved body.”;

(iii) in the third indent, for “notified” substitute “approved”;

(d) in Section 3—

(i) for each reference to “Article 5” substitute “regulation 3A of these Regulations”;

(ii) for “ Directive 2003/32/EC ” substitute “Commission Regulation 722/2012”;

(e) for Sections 4 and 5 substitute—

“4. The approved body must—

4.1. examine and assess the documentation, verify that the type has been manufactured in accordance with that documentation; it must also record the items which have been designed in accordance with the applicable provisions of the standards referred to in regulation 3A of the Regulations, as well as the items for which the design is not based on the relevant provisions of the said standards;

4.2. carry out or arrange for the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements of the Regulations where the standards referred to in regulation 3A of the Regulations have not been applied; if the device is to be connected to another device or other devices in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device having the characteristics specified by the manufacturer;

4.3. carry out or arrange for the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied;

4.4. agree with the applicant on the place where the necessary inspections and tests will be carried out.

5. Where the type meets the provisions of the Regulations, the approved body must issue a type-examination certificate to the applicant. The certificate must contain the name and address of the manufacturer, the conclusions of the inspection, the conditions under which the certificate is valid and the information necessary for identification of the type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the approved body.

In the case of devices referred to in Annex I, Section 7.4, second paragraph, the approved body must, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body must give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State.

In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.

In the case of devices manufactured utilizing tissues of animal origin referred to in Commission Regulation 722/2012, the approved body must follow the procedures referred to in that Regulation.”;

(f) in Section 6—

(i) for each reference to “notified body” substitute “approved body”;

(ii) omit each reference to “EC”;

(g) for Section 7.2 substitute—

“7.2. An approved body must cooperate with other approved bodies with regard to making available copies of the type-examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.”.

(h) in Section 7.3 —

(i) for “authorised representative” substitute “UK responsible person”;

(ii) omit “EC”.

15. In Annex IV—

(a) omit “EC” (including in the title) each time it occurs;

(b) for both references to “this Directive” substitute “the Regulations”;

(c) for each reference to “the Directive” substitute “the Regulations”;

(d) in Section 1 for “authorized representative” substitute “UK responsible person”;

(e) in Section 2—

(i) for “CE marking” substitute “UK marking”;

(ii) for “Article 17” substitute “regulation 10 of the Regulations”;

[F563 (f) omit Section 3;F563]

(g) for Sections 4 to 6 substitute—

“4. The approved body must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of the Regulations either by examining and testing every product as specified in Section 5 or by examining and testing products on a statistical basis as specified in Section 6, as the manufacturer decides.

The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility.

5. Verification by examination and testing of every product

5.1. Every product must be examined individually and the appropriate tests defined in the relevant standards referred to in regulation 3A of the Regulations must be carried out in order to verify, where appropriate, the conformity of the products with the type described in the type-examination certificate and with the requirements of the Regulations which apply to them.

5.2. The approved body must affix, or have affixed its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out.

6. Statistical verification

6.1. The manufacturer must present the manufactured products in the form of homogeneous batches.

6.2. A random sample must be taken from each batch. The products which make up the sample are examined individually and the appropriate tests defined in the relevant standards referred to in regulation 3A of the Regulations or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the type-examination certificate and with the requirements of the Regulations which apply to them in order to determine whether to accept or reject the batch.

6.3. Statistical control of products will be based on attributes and/or variables entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the designated standards referred to in regulation 3A of the Regulations, taking account of the specific nature of the product categories in question.

6.4. If the batch is accepted, the approved body affixes or has affixed its identification number to each product and draws up a written certificate of conformity relating to the tests carried out. All products in the batch may be put on the market except any in the sample which failed to conform.

If a batch is rejected, the approved body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the approved body may suspend the statistical verification.

The manufacturer may, on the responsibility of the approved body, affix the approved body’s identification number during the manufacturing process.”;

(h) in Section 7—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “national authorities” substitute “Secretary of State”;

(i) in Section 8, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”;

[F564 (zj) in Section 8.2 for “notified body” substitute “approved body”; F564]

(j) in Section 9—

(i) for the words “referred to in Article 1(4a)” substitute “which incorporate a substance derived from human blood or human plasma”;

[F565 (ia) for “notified body” substitute “approved body”; F565]

(ii) for the words from “a State laboratory” to the end of that Section, substitute “a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012 ”.

16. In Annex V—

(a) for “notified body” each time it occurs substitute “approved body”;

(b) omit “EC” each time it occurs, including in the title;

(c) in Section 1, omit “Community”;

(d) in Section 2—

(i) for “this Directive” substitute “the Regulations”;

(ii) for “CE marking in accordance with Article 17” substitute “UK marking”;

[F566 (e) omit the eighth indent of Section 3.1;F566]

(f) in Section 3.3, for the first sentence substitute—

“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2.”;

(g) in Section 3.4, for the last two paragraphs substitute—

“The proposed changes must be evaluated by the approved body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.”;

(h) in Section 5.1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “national authorities” substitute “Secretary of State”;

(i) in Section 6 for each reference to “this Directive” substitute “the Regulations”;

(j) in Section 6.3, for “competent authority” substitute “Secretary of State”;

(k) in Section 7—

(i) for the words “referred to in Article 1(4a)” substitute “which incorporate a substance derived from human blood or human plasma”;

(ii) for the words from “a State laboratory” to the end of that Section, substitute “a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012 .”.

17. In Annex VI—

(a) omit “EC” each time it occurs including in the title;

(b) for “the notified body” each time it occurs substitute “the approved body”;

(c) for “this Directive” each time it occurs substitute “the Regulations”;

(d) in Section 2—

(i) for “CE marking in accordance with Article 17” substitute “UK marking”;

(ii) for “CE marking must” substitute “UK marking must”;

[F567 (e) in Section 3.1–

(i) for “a notified body” substitute “an approved body” ;

(ii) for “other notified body” substitute “other approved body” ;

(iii) omit the eighth indent;F567]

(f) in Section 3.3, for the first sentence substitute—

“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2.”;

(g) in Section 3.4, for the second paragraph substitute—

“The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.”;

[F568 (ga) in Section 4.4 for “Article 5” substitute “regulation 3A of the Regulations”; F568]

(h) in Section 5.1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “national authorities” substitute “Secretary of State”;

(i) in Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”;

(j) in Section 6.3, for “competent authority” substitute “Secretary of State”.

[F569 (k) in Section 6.4 for “notified body” substitute “approved body”. F569]

18. In Annex VII—

(a) in the title and in Section 1, omit “EC”;

(b) in Section 1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “this Directive” substitute “the Regulations”;

(c) in Section 2 for—

(i) “his authorised representative” substitute “the manufacturer’s UK responsible person”;

(ii) “national authorities” substitute “Secretary of State”;

(d) in Section 3—

(i) in the opening paragraph for “the Directive” substitute “the Regulations”;

(ii) in the fourth indent—

(aa) for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;

(bb) for “of the Directive” substitute “in Annex I”;

[F570 (e) omit Section 4;F570]

(f) in Section 5, for “the intervention by the notified body” substitute “the intervention by the approved body”;

(g) in Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”.

19. In Annex VIII—

(a) in Section 1, for “authorized representative” substitute “UK responsible person”;

(b) in Section 2.2 in the seventh indent for “ Directive 2003/32/EC ” substitute “Regulation 722/2012”;

(c) in Section 3, for “competent national authorities” substitute “Secretary of State”;

(d) in Sections 3.1 and 3.2, for “this Directive” each time it occurs substitute “the Regulations”;

(e) in Section 3.2—

(i) in the fourth indent, for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;

(ii) in the sixth indent, for “ Directive 2003/32/EC ” substitute “Regulation 722/2012”;

[F571 (f) omit Section 5.F571]

20. In Annex IX for “this Directive” each time it occurs substitute “the Regulations”.

21. In Annex X—

(a) in Section 1.1 for “harmonised standards” substitute “designated standards”;

(b) in Section 2.3.5 for the words from “all competent authorities of the Member States” to the end substitute “the Secretary of State”.

22. In Annex X1—

(a) in the title, for “notified bodies” substitute “approved bodies”;

(b) for the words “notified body” each time they occur substitute “approved body”;

(c) for each reference to “the Directive” substitute “the Regulations”;

(d) in Section 2, for “national authorities” substitute [F572 “Secretary of State” F572] ;

(e) in Section 3, for “this Directive” substitute “the Regulations”;

(f) in Section 6, omit the words from “, unless liability” to the end of that Section;

(g) in Section 7, omit the words from “(except vis a vis the competent administrative authorities” to the end.

23. Omit Annex XII.

PART 3 Modification of Annexes to Directive 98/79

24.—(1) The Annexes to Directive 98/79 are modified so that they read as if amended by paragraphs 25 to 33.

(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002 .

25. In Annex 1—

(a) in Section 3 in part A, for “Article 1(2)(b)” substitute “regulation 2(1) of the Regulations”;

(b) in Section 4.2 in part B, for “Council Directive 80/181/EEC of 20th December 1979” substitute “ the Units of Measurement Regulations 1986 ”;

(c) in Section 8.1 in part B, omit the words from “The decision whether” to the end;

(d) in Section 8.2 in part B, for “harmonised standards” substitute “designated standards”;

(e) in Section 8.3 in part B —

(i) in the first sentence omit “of Directive 67/548/EEC and Directive 88/379/EEC ”;

(ii) in the second sentence omit “by those Directives”;

(iii) omit the words from “The provisions of” to the end;

(f) in Section 8.4 in point (a), for the sentence beginning “For devices imported”, substitute—

“Where the manufacturer does not have a registered place of business in the United Kingdom the label, the outer packaging or instructions for use shall contain in addition the name and address of the UK responsible person.”.

26. In Annex III—

(a) in the title and in Section 1, omit “EC”;

(b) in Section 1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “this Directive” substitute “the Regulations”;

(iii) for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;

(c) in Section 3, for “the Directive” in both places substitute “the Regulations”;

(d) in Section 3, in the sixth indent, for “Article 5” in both places substitute “regulation 3A of the Regulations”;

[F573 (e) omit Section 5;F573]

(f) in Section 6, for “a notified body” substitute “an approved body”;

(g) in Section 6.2—

(i) for “notified body”, both times those words occur, substitute “approved body”;

(ii) in the first sentence, for “this Directive” substitute “the Regulations”;

(iii) in the second sentence omit “of the Directive”;

(iv) for “an EC” substitute “a” ;

(h) in Section 6.3—

(i) for “notified body” in both places substitute “approved body”;

(ii) omit each reference to “EC”;

(iii) for “the Directive” substitute “the Regulations”.

27. In Annex IV—

(a) in the title, omit “EC”;

(b) for each reference to “this Directive” and “the Directive” substitute “the Regulations”;

(c) in Section 2, for “CE marking” substitute “UK marking”;

(d) in Section 3.1—

(i) for “of his quality system with a notified body” substitute “of its quality system with an approved body”;

(ii) in the third indent for “notified body” substitute “approved body”;

[F574 (iii) omit the final indent;F574]

(e) in Section 3.3 for the first paragraph substitute—

“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant designated standards conform to the requirements.”;

(f) in Section 3.4, in both paragraphs, for “notified body” substitute “approved body”;

(g) in Section 4.1 for “notified body” substitute “approved body”;

(h) in Section 4.3—

(i) for “notified body” both times those words occur substitute “approved body”;

(ii) for “an EC” substitute “a”;

(i) in Section 4.4—

(i) for “notified body” both times those words occur substitute “approved body”;

(ii) omit each reference to “EC”;

(j) in Section 4.5, for “notified body” both times those words occur substitute “approved body”;

(k) in Sections 5 and 6 for “notified body” each time those words occur substitute “approved body”.

28. In Annex V—

(a) in the title, omit “EC” ;

(b) in Section 1—

(i) for “EC type-examination” substitute “Type-examination”;

(ii) for “a notified body” substitute “an approved body”;

(iii) for “this Directive” substitute “the Regulations”;

(c) in Section 2—

(i) in the first paragraph—

(aa ) omit “EC”;

(bb) for “his authorised representative” substitute “its UK responsible person”;

(cc) for “a notified body” substitute “an approved body”;

(ii) in the first indent—

(aa) for “authorised representative” substitute “UK responsible person”;

(bb) for “the representative” substitute “the UK responsible person”;

(iii) in the second indent for “this Directive” substitute “the Regulations”;

(iv) in the second and third indents for “notified body” each time those words occur substitute “approved body”;

(d) in Section 4—

(i) for “notified body shall” substitute “approved body must”;

(ii) for both references to “Article 5” substitute “regulation 3A of the Regulations”;

(iii) for “this Directive” substitute “the Regulations”;

(e) in Section 5—

(i) for “this Directive” substitute “the Regulations”;

(ii) for “notified body” in both places substitute “approved body”;

(iii) for “an EC” substitute “a”;

(f) in Section 6—

(i) for “notified body” each time it occurs substitute “approved body”;

(ii) omit “EC” each time it occurs;

(iii) for “the Directive” substitute “the Regulations”;

(g) for Section 7, substitute—

“7. An approved body must cooperate with other approved bodies with regard to making available copies of the type-examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.”.

29. In Annex VI—

(a) in the title omit “EC”;

(b) in Section 1—

(i) for “EC verification” substitute “Verification”;

(ii) for “authorised representative” substitute “UK responsible person”;

(iii) for “EC type-examination” substitute “type-examination”;

(iv) for “this Directive” substitute “the Regulations”;

(c) in Section 2.1—

(i) for “EC type-examination” in both places substitute “type-examination”;

(ii) for “the Directive” substitute “the Regulations”;

(iii) for “this Directive” substitute “the Regulations”;

(d) in Section 2.2 for “notified body” substitute “approved body”;

[F575 (da) omit Section 3;F575]

(e) in Section 4—

(i) for “notified body” in both places substitute “approved body”;

(ii) for “the Directive” substitute “the Regulations”;

(f) in Section 5.1—

(i) for “Article 5” substitute “regulation 3A of the Regulations”;

(ii) omit “EC”;

(iii) for “the Directive” substitute “the Regulations”;

(g) in Section 5.2 for “notified body” substitute “approved body”;

(h) in Section 6.2—

(i) for “Article 5” substitute “regulation 3A of the Regulations”;

(ii) omit “EC”;

(iii) for “the Directive” substitute “the Regulations”;

(i) in Section 6.3 for “the harmonised standards referred to in Article 5” substitute “the designated standards referred to in regulation 3A of the Regulations”;

(j) in Section 6.4—

(i) for the first two paragraphs, substitute—

“Where the approved body has drawn up a written certificate of conformity in relation to a batch, all products in that batch to which that body has affixed, or caused to be affixed, an identification number may be placed on the market.”;

(ii) in the third paragraph, for “notified body”, in both places, substitute “approved body”.

30. In Annex VII—

(a) in the title and in Section 2, omit “EC”;

(b) in Section 2—

(i) for “this Directive” substitute “the Regulations”;

(ii) for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;

(c) in Section 3.1—

(i) for “a notified body” substitute “an approved body”;

(ii) for “EC type-examination” substitute “type-examination”;

(d) in Section 3.2, for “EC type-examination” substitute “type-examination”;

(e) in Section 3.3 for the first two sentences substitute—

“The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. The approved body must presume that quality systems which implement the relevant designated standards conform to the requirements.”;

(f) in Section 3.4—

(i) for “notified body” substitute “approved body”;

(ii) for the first sentence of the second paragraph substitute “The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would meet the requirements referred to in Section 3.2.”;

(g) in Sections 5.1 and 5.2, for each reference to “notified body” substitute “approved body”.

31. In Annex VIII—

(a) in Section 1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “this Directive” substitute “the Regulations”;

(b) in Section 2, for “the Directive” substitute “the Regulations”;

(c) in Section 3—

(i) for “competent national authorities” substitute “Secretary of State”;

(ii) for “this Directive” substitute “the Regulations”.

32. In Annex IX—

(a) in the title, for “notified bodies” substitute “approved bodies”;

(b) for each reference to “notified body” substitute “approved body”;

(c) in Section 1, for “authorised representative” substitute “UK responsible person”;

(d) in Section 2—

(i) for “the Directive” substitute “the Regulations”;

(ii) for “national authorities” substitute “Secretary of State”;

(iii) for “this Directive” substitute “the Regulations”;

(e) in Section 3—

(i) for “has been notified” substitute “has been designated”;

(ii) for “this Directive” substitute “the Regulations”;

(f) in Section 6, omit the words from “unless liability” to the end;

(g) in Section 7, omit the words from “(except vis à vis the competent administrative authorities” to the end.

33. Omit Annex X.F547]

Status: The Medical Devices Regulations 2002 is up to date with all changes known to be in force on or before 07 August 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
The Medical Devices Regulations 2002 (2002/618)
Version from: 16 July 2025

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Status of this instrument

in force Provision is in force
in force* In force only for specified purposes (see footnote)
not in force Not in force in England (may be in force in other geographies, see footnotes)
defined term Defined term
dfn Defined term (alternative style)
footnote commentary transitional and savings in force status related provisions geo extent insert/omit source count in force adj
C1 Regulations: power to amend conferred (11.2.2021) by Medicines and Medical Devices Act 2021 (c. 3), ss. 15(1), 50(1)(f)
E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E2 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E3 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E4 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E5 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E6 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E7 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E8 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E9 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E10 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E11 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E12 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E13 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E14 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E15 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E16 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E17 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E18 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E19 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E20 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E21 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E22 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E23 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E24 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E25 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E26 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E27 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E28 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E29 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E30 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E31 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E32 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E33 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E34 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E35 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E36 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E37 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E38 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E39 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E40 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E41 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E42 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E43 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E44 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E45 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E46 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E47 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only for the substitution of Sch. 2 in relation to E.W.S. (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(10) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
E48 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
E49 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E50 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E51 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E52 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E53 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E54 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E55 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E56 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E57 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E58 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E59 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E60 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E61 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E62 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E63 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E64 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E65 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E66 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E67 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E68 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E69 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E70 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E71 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E72 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E73 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E74 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E75 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E76 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E77 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E78 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E79 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E80 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E81 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E82 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E83 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E84 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E85 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E86 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E87 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E88 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E89 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E90 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E91 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E92 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E93 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E94 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
E95 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
F1 Reg. 1ZA substituted (30.6.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(1), 4 substituted
F2 Regs. 1ZA, 1A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(2) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 3); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F3 Words in reg. 2(1) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 1(a) omitted: England, Wales and Scotland omitted
F4 Words in reg. 2(1) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 2(a) omitted
F5 Words in reg. 2(1) omitted (26.5.2021) by virtue of Medicines and Medical Devices Act 2021 (c. 3), ss. 41(4), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F5 Words in reg. 2(1) omitted (26.5.2021) by virtue of Medicines and Medical Devices Act 2021 (c. 3), ss. 41(4), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F6 Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(a) omitted
F7 Words in reg. 2 inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(aa) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(a)); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F8 Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F9 Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(b)); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F10 Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(da) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(c)); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F11 Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(c) inserted
F12 Words in reg. 2 inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 3 inserted
F12 Words in reg. 2 inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 3 inserted
F13 Words in reg. 2 inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(d) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F14 Words in reg. 2(1) substituted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(a)(i) substituted
F15 Words in reg. 2 inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(e) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(d)); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F16 Words in reg. 2(1) substituted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(a)(ii) substituted
F17 Words in reg. 2 inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(f) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(e)); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F18 Words in reg. 2(1) substituted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(a)(iii) substituted
F19 Words in reg. 2 inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(g) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(f)); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F20 Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(h) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F21 Words in reg. 2(1) inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 2(c) inserted
F22 Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(b) omitted
F23 Words in reg. 2(1) inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 2(a) inserted
F24 Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(d) inserted
F25 Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F26 Word in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(j) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F27 Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(c) omitted
F28 Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(ia) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(g)(h)); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F29 Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(k) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F30 Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(e) inserted
F31 Words in reg. 2(1) inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 2(b) inserted
F32 Words in reg. 2(1) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(f) substituted
F33 Words in reg. 2 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(l) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(i)); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F34 Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(g) inserted
F35 Words in reg. 2 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(m) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F36 Words in reg. 2(1) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(h) substituted
F37 Words in reg. 2(1) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(4) substituted
F38 Words in reg. 2(1) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(i) omitted
F39 Words in reg. 2 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(n) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F40 Words in reg. 2 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(o) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F41 Words in reg. 2(1) substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 1(b) substituted: England, Wales and Scotland substituted
F42 Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(p) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F43 Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(d) omitted
F44 Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(q) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(j)); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F45 Words in reg. 2 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(r)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(k)); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F46 Words in reg. 2 inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(r)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F47 Words in reg. 2 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(s) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(l)); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F48 Words in reg. 2(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(5) inserted
F49 Words in reg. 2(1) inserted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 1(c) inserted: England, Wales and Scotland inserted
F50 Words in reg. 2(1) substituted (E.W.S.) (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 3(b) substituted: England, Wales and Scotland substituted
F51 Words in reg. 2(1) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 5 inserted: England, Wales and Scotland inserted
F52 Words in reg. 2(1) inserted (E.W.S.) (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 9 inserted: England, Wales and Scotland inserted
F53 Words in reg. 2(1) substituted (E.W.S.) (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 3(a) substituted: England, Wales and Scotland substituted
F54 Words in reg. 2 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(t) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F55 Words in reg. 2(1) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 4 inserted: England, Wales and Scotland inserted
F56 Words in reg. 2 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(u) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F57 Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(e) omitted
F58 Words in reg. 2 inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(ua) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 24(m)); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F59 Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(v) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(n)); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F60 Words in reg. 2 inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(w) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(o)); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F61 Words in reg. 2(1) inserted (E.W.S.) (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 3(c) inserted: England, Wales and Scotland inserted
F62 Reg. 2(1A) inserted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(b) inserted
F63 Words in reg. 2(1A) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(4) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 5); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F64 Reg. 2(1B) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(6) inserted
F65 Reg. 2A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(4A) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 6); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F66 Words in reg. 2A(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 11(a)(i) inserted
F67 Reg. 2A(1)(a) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 11(a)(ii) substituted
F68 Reg. 2A(1A) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 11(b) inserted
F69 Words in reg. 2A(2) renumbered as reg. 2A(2)(a) (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 31(b)(i) renumbered
F70 Reg. 2A(2)(b) inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 31(b)(ii) inserted
F71 Words in reg. 3(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(5)(c)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F72 Words in reg. 3(a) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(5)(c)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F73 Words in reg. 3(c) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(a) substituted
F74 Words in reg. 3(d) inserted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(b) inserted
F75 Words in reg. 3(d) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(a) omitted
F76 Words in reg. 3(d) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(b) inserted
F77 Reg. 3(e) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(c) substituted
F78 Words in reg. 3(e)(ii) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(c) omitted
F79 Words in reg. 3(f) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(5)(d) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F80 Reg. 3(g) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(d) omitted
F81 Reg. 3ZA inserted (N.I.) (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 32 inserted: Northern Ireland inserted
F82 Words in reg. 3ZA heading inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(a) inserted
F83 Reg. 3ZA(1) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(b) substituted
F84 Words in reg. 3ZA(2) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(c)(i) omitted
F85 Reg. 3ZA(2)(a)(aa) substituted for reg. 3ZA(2)(a) (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(c)(ii) substituted
F86 Word in reg. 3ZA(2)(b) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(c)(iii) inserted
F87 Words in reg. 3ZA(3) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(i) substituted
F88 Words in reg. 3ZA(3) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(ii) inserted
F89 Words in reg. 3ZA(3)(a) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(iii) substituted
F90 Words in reg. 3ZA(3)(b) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(iv) omitted
F91 Regs. 3A, 3B inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(6) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 2 and S.I. 2020/1478, regs. 1(2)(3), 4(2), Sch. 2 paras. 2, 8); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F91 Regs. 3A, 3B inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(6) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 2 and S.I. 2020/1478, regs. 1(2)(3), 4(2), Sch. 2 paras. 2, 8); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F92 Words in reg. 3A(1)(a)(i) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 1(a); S.I. 2020/1662, reg. 2(ee) inserted
F93 Reg. 3A(3A) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 1(b); S.I. 2020/1662, reg. 2(ee) inserted
F94 Word in reg. 3A(5) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 1(c)(i); S.I. 2020/1662, reg. 2(ee) inserted
F95 Words in reg. 3A(5) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 1(c)(ii); S.I. 2020/1662, reg. 2(ee) inserted
F96 Reg. 3B omitted (26.5.2021) by virtue of Medicines and Medical Devices Act 2021 (c. 3), ss. 41(5), 50(3); S.I. 2021/610, reg. 2(c) (with reg. 3) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F97 Reg. 4(5) inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 3(a) inserted
F98 Reg. 4(6) added (1.4.2004) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(b), 3(b) added
F99 Reg. 4A inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 4 inserted
F100 Reg. 4D inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F101 Reg. 4H omitted (24.5.2025) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2025 (S.I. 2025/591), regs. 1(2), 2(2)(a) omitted
F102 Regs. 4H-4P inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F102 Regs. 4H-4P inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F102 Regs. 4H-4P inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F102 Regs. 4H-4P inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F102 Regs. 4H-4P inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F102 Regs. 4H-4P inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F102 Regs. 4H-4P inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F102 Regs. 4H-4P inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F103 Reg. 4J omitted (24.5.2025) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2025 (S.I. 2025/591), regs. 1(2), 2(2)(b) omitted
F104 Reg. 4K omitted (24.5.2025) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2025 (S.I. 2025/591), regs. 1(2), 2(2)(c) omitted
F105 Reg. 4L omitted (24.5.2025) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2025 (S.I. 2025/591), regs. 1(2), 2(2)(d) omitted
F106 Reg. 4N omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 6 omitted: England, Wales and Scotland omitted
F107 Reg. 4T inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F108 Reg. 4T(1) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 13 omitted
F109 Reg. 4T(2)(b) omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 7(a)(i) omitted
F110 Reg. 4T(2)(c)(d) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 7(a)(ii) inserted
F111 Words in reg. 4T(4)(a) omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 7(b) omitted
F112 Words in reg. 5(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 4 omitted
F113 Words in reg. 5(1) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 4 substituted
F114 Word in reg. 6(a) inserted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 8(a) inserted: England, Wales and Scotland inserted
F115 Word in reg. 6(b) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 8(b) omitted: England, Wales and Scotland omitted
F116 Reg. 6(c) omitted (E.W.S) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 8(c) omitted
F117 Words in reg. 7 inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 5 inserted
F118 Words in reg. 7 inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 5 inserted
F119 Words in reg. 7(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(3) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 11); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F120 Reg. 7A inserted (E.W.S.) (30.4.2021) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(2)(a), 4(4) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 3 and S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 12); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F121 Words in reg. 8(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3 inserted
F122 Words in reg. 8(2) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3 inserted
F123 Reg. 8(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 5 added
F124 Words in reg. 8(3) substituted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(5) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F125 Words in reg. 9(3)(b)(i) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6)(a)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F126 Reg. 9(3)(b)(ii) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6)(a)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F127 Words in reg. 9(4) substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 9 substituted: England, Wales and Scotland substituted
F128 Reg. 9(5A) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 6(a) inserted
F129 Words in reg. 9(6) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6)(aa) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 13); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F130 Words in reg. 9(8) omitted (E.W.S.) (31.12.2020) by virtue of y The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6)(ab) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 13); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F131 Reg. 9(9) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 6(b) inserted
F132 Words in reg. 9(9) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6)(b)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F133 Words in reg. 9(9) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6)(b)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F134 Words in reg. 10 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F135 Words in reg. 10(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(b)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F136 Words in reg. 10(1)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(b)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F137 Words in reg. 10(1)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(b)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F138 Words in reg. 10(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(c)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F139 Words in reg. 10(2)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(c)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F140 Words in reg. 10(2)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(c)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F141 Words in reg. 10(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(d)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F142 Words in reg. 10(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(d)(ii)(aa) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F143 Words in reg. 10(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(d)(ii)(bb) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F144 Words in reg. 10(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(e)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F145 Words in reg. 10(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(e)(Ii)(aa) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F146 Words in reg. 10(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(e)(ii)(bb) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F147 Words in reg. 10(5) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(f) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F148 Reg. 10(6) inserted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 10 inserted: England, Wales and Scotland inserted
F149 Reg. 10A inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 3 inserted: Northern Ireland inserted
F150 Reg. 10A(3A) inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 33 inserted
F151 Reg. 11 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6B) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 15); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F152 Words in reg. 12(1) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 16); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F153 Words in reg. 12(3)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 16); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F154 Words in reg. 12(5) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 16); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F155 Reg. 12(6)(7) inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 16); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F156 Words in reg. 13 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F157 Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F158 Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F159 Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F160 Word in reg. 13(4)(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(a) omitted
F161 Word in reg. 13(4)(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(b) added
F162 Reg. 13(4)(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(c) added
F163 Reg. 13(5)(6) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(3) omitted
F164 Reg. 14(4)(a) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 7(a) substituted
F165 Reg. 14(4A) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 7(b) inserted
F166 Words in reg. 14(4A) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7B)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 18); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F167 Words in reg. 14(5)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7B)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 18); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F168 Words in reg. 15 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7C) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 19); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F169 Words in reg. 15(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 5 inserted
F170 Word in reg. 15(c) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 8(1) omitted
F171 Reg. 15(e) and word inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 8(2) inserted
F172 Words in reg. 16(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7D)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 20); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F173 Words in reg. 16 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7D)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 20); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F174 Words in reg. 16(1)(a) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 9(a) substituted
F175 Words in reg. 16(1)(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 6 inserted
F176 Reg. 16(1A) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 5 inserted: England, Wales and Scotland inserted
F177 Words in reg. 16(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7D)(c)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 20); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F178 Words in reg. 16(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7D)(c)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 20); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F179 Words in reg. 16(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7D)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 20); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F180 Reg. 16(11) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 9(b) added
F181 Words in reg. 16(11) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7D)(e) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 20); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F182 Words in reg. 17 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(8)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 21); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F183 Words in reg. 17 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(8)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 21); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F184 Reg. 17(3) omitted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(8)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 21); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F185 Reg. 17(4)(5) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 7 omitted
F186 Words in reg. 18 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(9)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 22); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F187 Words in reg. 18(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(9)(b)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 22); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F188 Words in reg. 18(1)(a) omitted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(9)(b)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 22); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F189 Words in reg. 18(1)(b) omitted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(9)(b)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 22); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F190 Words in reg. 18(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(9)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 22); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F191 Words in reg. 18(2) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 10 substituted
F192 Words in reg. 18(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(9)(d)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 22); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F193 Words in reg. 18(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(9)(d)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 22); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F194 Reg. 18(4) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(9)(e) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 22); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F195 Reg. 19 revoked (E.W.S) (30.4.2021) by S.I. 2002/618, reg. 4D(1) (as inserted by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)) inserted
F196 Reg. 19 substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 6 substituted: Northern Ireland substituted
F197 Reg. 19(1)(a)(ii) omitted (N.I.) (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 34(a) omitted: Northern Ireland omitted
F198 Words in reg. 19(1)(b) substituted (N.I.) (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 34(b) substituted: Northern Ireland substituted
F199 Reg. 19(2)(c) omitted (N.I.) (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 34(c) omitted: Northern Ireland omitted
F200 Reg. 19(5) omitted (N.I) (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 34(d) omitted
F201 Reg. 19(6) omitted (N.I.) (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 34(e) omitted: Northern Ireland omitted
F202 Reg. 19A omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 9 omitted
F203 Reg. 19B omitted (N.I.) (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 14 omitted: Northern Ireland omitted
F204 Regs. 19B, 19C inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(11) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 24); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F204 Regs. 19B, 19C inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(11) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 24); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F205 Words in reg. 19B(1)(a) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(2)(a) inserted: England, Wales and Scotland inserted
F206 Words in reg. 19B(1)(a) omitted (E.W.S.) (1.7.2023) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(2)(b) omitted: England, Wales and Scotland omitted
F207 Words in reg. 19B(3) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(3)(a) inserted: England, Wales and Scotland inserted
F208 Reg. 19B(3)(ba) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(3)(b) inserted: England, Wales and Scotland inserted
F209 Words in reg. 19B(3)(f) substituted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(3)(c) substituted: England, Wales and Scotland substituted
F210 Reg. 19B(3A) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(4) inserted: England, Wales and Scotland inserted
F211 Reg. 19B(7)(ba)(bb) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(5)(a) inserted: England, Wales and Scotland inserted
F212 Word in reg. 19B(7)(c) omitted (E.W.S.) (1.7.2023) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(5)(b) omitted: England, Wales and Scotland omitted
F213 Words in reg. 19B(7)(d) substituted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(5)(c) substituted: England, Wales and Scotland substituted
F214 Reg. 19B(7)(e) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(5)(d) inserted: England, Wales and Scotland inserted
F215 Reg. 19C(3)(ba) inserted (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 7(2) inserted
F216 Reg. 19C(7) substituted (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 7(3) substituted
F217 Words in reg. 20(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 10(a) omitted
F218 Words in reg. 20(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 10(b) omitted
F219 Reg. 21 renumbered as reg. 21(1) (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(a) renumbered
F220 Words in reg. 21(1) omitted (E.W.S) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 11(a) omitted
F221 Reg. 21(2)(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(b) added
F222 Words in reg. 21(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(2)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F223 Reg. 21(3) substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 11(b) substituted: England, Wales and Scotland substituted
F224 Reg. 21(4) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 11(c) omitted: England, Wales and Scotland omitted
F225 Reg. 21A inserted (E.W.S.) (30.4.2021) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(2)(b), 5(3) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 4 and S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 25); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F226 Regs. 21B, 21C inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 8 inserted: Northern Ireland inserted
F227 Reg. 21B(1)(a)(ii) omitted (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 35(a) omitted
F228 Reg. 21B(1)(b) omitted (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 35(b) omitted
F229 Reg. 21B(2)(c) omitted (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 35(c) omitted
F230 Reg. 21B(5) omitted (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 35(d) omitted
F231 Reg. 21B(6) omitted (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 35(e) omitted
F232 Reg. 21C omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 15 omitted
F233 Words in reg. 22(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 10 inserted
F234 Words in reg. 22(2) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 10 inserted
F235 Words in reg. 23(3)(b)(i) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F236 Reg. 23(3)(b)(ii) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F237 Words in reg. 23(4) substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 12 substituted: England, Wales and Scotland substituted
F238 Words in reg. 24 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F239 Words in reg. 24 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F240 Words in reg. 24 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F241 Words in reg. 24(1)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(d)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F242 Words in reg. 24(2)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(d)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F243 Words in reg. 24(3)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(d)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F244 Words in reg. 24(4)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(d)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F245 Reg. 24(6) inserted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 13 inserted: England, Wales and Scotland inserted
F246 Reg. 24A inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 9 inserted: Northern Ireland inserted
F247 Reg. 24A(3A) inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 36 inserted
F248 Reg. 25 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4B) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F249 Words in reg. 26(1) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 28); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F250 Words in reg. 26(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 28); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F251 Reg. 26(4)(5) inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 28); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F252 Words in reg. 27 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5A)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 29); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F253 Words in reg. 27 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5A)(b)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 29); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F254 Words in reg. 27 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5A)(b)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 29); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F255 Words in reg. 27(b)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5A)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 29); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F256 Word in reg. 27(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(a) omitted
F257 Word in reg. 27(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(b) added
F258 Reg. 27(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(c) added
F259 Words in reg. 28 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5B) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 30); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F260 Words in reg. 28(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 12 inserted
F261 Words in reg. 29(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5C)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 31); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F262 Words in reg. 29 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5C)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 31); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F263 Words in reg. 29(1)(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 13 inserted
F264 Reg. 29(1A) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 6 inserted: England, Wales and Scotland inserted
F265 Words in reg. 29(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5C)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 31); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F266 Reg. 29(10) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 13 added
F267 Words in reg. 29(10) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5C)(d) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 31); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F268 Words in reg. 30(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(6)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 32); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F269 Words in reg. 30(1) substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 14(a) substituted: England, Wales and Scotland substituted
F270 Words in reg. 30(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(6)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 32); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F271 Words in reg. 30(2) inserted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 14(b)(i) inserted: England, Wales and Scotland inserted
F272 Words in reg. 30(2) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 14(b)(ii) omitted: England, Wales and Scotland omitted
F273 Reg. 30(3) revoked (E.W.S.) (30.4.2021) by S.I. 2002/618, reg. 4D(6) (as inserted (E.W.S.) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)) inserted: England, Wales and Scotland inserted
F274 Reg. 30(4)(5) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(6)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 32); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F275 Reg. 30A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(8) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 34); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F276 Words in reg. 30A(1)(a) inserted (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 8(2)(a) inserted
F277 Words in reg. 30A(1)(a) omitted (1.7.2023) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 8(2)(b) omitted
F278 Reg. 30A(3)(ba) inserted (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 8(3)(a) inserted
F279 Words in reg. 30A(3)(f) substituted (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 8(3)(b) substituted
F280 Words in reg. 31 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(7)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 33); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F281 Words in reg. 31(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(7)(b)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 33); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F282 Words in reg. 31(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(7)(b(ii)) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 33); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F283 Words in reg. 31(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(7)(b)(iii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 33); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F284 Words in reg. 31(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(7)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 33); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F285 Words in reg. 31(2) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 15 substituted
F286 Words in reg. 31(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(7)(d)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 33); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F287 Words in reg. 31(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(7)(d)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 33); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F288 Words in reg. 32(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 11 omitted
F289 Words in reg. 32 substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 15 substituted: England, Wales and Scotland substituted
F290 Words in reg. 33(1) inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 4 inserted
F291 Word in reg. 33(1)(a) omitted (E.W.S) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 16(a)(i) omitted
F292 Reg. 33(1)(b) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 16(a)(ii) omitted: England, Wales and Scotland omitted
F293 Word in reg. 33(2)(a) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 16(b)(i) omitted: England, Wales and Scotland omitted
F294 Reg. 33(2)(b) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 16(b)(ii) omitted: England, Wales and Scotland omitted
F295 Reg. 33A inserted (E.W.S.) (30.4.2021) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(2)(c), 6(3) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 5 and S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 36); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F296 Regs. 34A-34C inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 5 inserted
F296 Regs. 34A-34C inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 5 inserted
F296 Regs. 34A-34C inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 5 inserted
F297 Words in reg. 34A(1) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 16 substituted
F298 Words in reg. 34A(2) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 16 substituted
F299 Reg. 34D inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 17 inserted
F300 Words in reg. 35(2) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 37); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F301 Words in reg. 35(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 37); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F302 Words in reg. 36 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4A)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 38); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F303 Words in reg. 36 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4A)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 38); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F304 Words in reg. 36 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4A)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 38); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F305 Words in reg. 36 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4A)(d) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 38); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F306 Reg. 36(6) inserted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 17 inserted: England, Wales and Scotland inserted
F307 Reg. 36A inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 13 inserted: Northern Ireland inserted
F308 Reg. 36A(3A) inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 37 inserted
F309 Reg. 37 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(4B) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 39); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F310 Regs. 38A-38C inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 6 inserted
F310 Regs. 38A-38C inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 6 inserted
F310 Regs. 38A-38C inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 6 inserted
F311 Words in reg. 39 heading substituted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 7 substituted
F312 Words in reg. 39(1)(b) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(5)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 40); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F313 Words in reg. 39(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(5)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 40); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F314 Reg. 39(3)(4) inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(5)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 40); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F315 Reg. 39A inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 8 inserted
F316 Words in reg. 40 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F317 Words in reg. 40 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F318 Words in reg. 40 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F319 Words in reg. 40 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F320 Words in reg. 41 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(6)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 42); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F321 Words in reg. 41 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(6)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 42); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F322 Words in reg. 41(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(6)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 42); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F323 Words in reg. 41(3)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(6)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 42); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F324 Reg. 41(5) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 18 omitted: England, Wales and Scotland omitted
F325 Words in reg. 42 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F326 Words in reg. 42(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(b)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F327 Words in reg. 42(1)(a) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(b)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F328 Words in reg. 42(1)(b) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(b)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F329 Words in reg. 42(1)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(b)(iv) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F330 Words in reg. 42(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F331 Words in reg. 42(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(d)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F332 Words in reg. 42(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(d)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F333 Words in reg. 43 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(8)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 44); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F334 Words in reg. 43(b)(ii) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(8)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 44); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F335 Reg. 44 revoked (E.W.S.) (30.4.2021) by S.I. 2002/618, reg. 4D(8) (as inserted by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)) inserted: England, Wales and Scotland inserted
F336 Regs. 44, 44ZA substituted for reg. 44 (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 15 substituted: Northern Ireland substituted
F337 Reg. 44(1)(a)(ii) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 18(a) omitted
F338 Reg. 44(2)(c) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 18(b) omitted
F339 Reg. 44(5) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 18(c) omitted
F340 Reg. 44(6) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 18(d) omitted
F341 Reg. 44ZA omitted (N.I.) (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 19 omitted: Northern Ireland omitted
F342 Regs. 44ZA, 44ZB inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(10) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 46); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F342 Regs. 44ZA, 44ZB inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(10) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 46); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F343 Words in reg. 44ZA(1)(a) substituted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 9(2) substituted: England, Wales and Scotland substituted
F344 Words in reg. 44ZA(3) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 9(3)(a) inserted: England, Wales and Scotland inserted
F345 Reg. 44ZA(3)(ba) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 9(3)(b) inserted: England, Wales and Scotland inserted
F346 Words in reg. 44ZA(3)(f) substituted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 9(3)(c) substituted: England, Wales and Scotland substituted
F347 Reg. 44ZA(3A) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 9(4) inserted: England, Wales and Scotland inserted
F348 Reg. 44ZB(3)(ba) inserted (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 10 inserted
F349 Pt. 4A inserted (E.W.S.) (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 4 inserted: England, Wales and Scotland inserted
F350 Words in Pt. 5 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(2) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F351 Reg. 44A inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 12 inserted
F352 Reg. A45 inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(3) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47(3)); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F353 Words in reg. 45 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F354 Words in reg. 45(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(b)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F355 Words in reg. 45(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(b)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F356 Words in reg. 45(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(b)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F357 Words in reg. 45(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F358 Word in reg. 45(2)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(d)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F359 Words in reg. 45(2)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(d)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F360 Words in reg. 45(2)(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(2) inserted
F361 Words in reg. 45(2)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(e)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F362 Words in reg. 45(2)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(f)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F363 Words in reg. 45(2)(b) inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 13(a) inserted
F364 Words in reg. 45(2)(b) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(3) substituted
F365 Words in reg. 45(2)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(f)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F366 Words in reg. 45(2)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(f)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F367 Words in reg. 45(2)(d) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(g) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F368 Words in reg. 45(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(h) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F369 Words in reg. 45(5)(b) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(4) substituted
F370 Words in reg. 45(5)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F371 Words in reg. 45(6) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(j)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F372 Words in reg. 45(6) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(j)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F373 Words in reg. 45(7) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(4) substituted
F374 Words in reg. 45(7) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(k) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F375 Words in reg. 45(8) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(l)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F376 Words in reg. 45(8) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(4) substituted
F377 Words in reg. 45(8)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(l)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F378 Reg. 46 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(5)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F379 Words in reg. 46 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(5)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F380 Words in reg. 46 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(5)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F381 Words in reg. 46 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(5)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F382 Reg. 47 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F383 Words in reg. 47(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(b)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F384 Words in reg. 47(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(b)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F385 Words in reg. 47(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(b)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F386 Words in reg. 47(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(b)(iv) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F387 Words in reg. 47(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(c)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F388 Words in reg. 47(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(c)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F389 Words in reg. 47(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(d)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F390 Words in reg. 47(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(d)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F391 Words in reg. 47(3) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(d)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F392 Words in reg. 47(3) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(d)(iv) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F393 Words in reg. 47(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(e)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F394 Words in reg. 47(4)(5) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 16 omitted
F395 Words in reg. 47(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(e)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F396 Words in reg. 47(5) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(f)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F397 Words in reg. 47(5)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(f)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F398 Words in reg. 47(5) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(f)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F399 Words in reg. 47(6) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(g)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F400 Words in reg. 47(6) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(g)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F401 Words in reg. 47(8) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(h)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F402 Words in reg. 47(8) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(h)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F403 Reg. 47(9)(10) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 15 omitted
F404 Reg. 47A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(7) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47(7)); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F405 Word in reg. 48 heading omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F406 Words in reg. 48(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(b)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F407 Words in reg. 48(1) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(b)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F408 Words in reg. 48(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(b)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F409 Words in reg. 48(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(c)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F410 Words in reg. 48(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(c)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F411 Words in reg. 48(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F412 Words in reg. 48(5)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(e)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F413 Words in reg. 48(5)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(e)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F414 Word in reg. 48(6) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(f) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F415 Words in reg. 48(7) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(g)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F416 Words in reg. 48(7) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(g)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F417 Words in reg. 48(8) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(h)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F418 Words in reg. 48(8) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(h)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F419 Reg. 49 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(9)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F420 Words in reg. 49(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(9)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F421 Reg. 49(1)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(9)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F422 Words in reg. 49(1)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(9)(d)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F423 Words in reg. 49(1)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(9)(d)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F424 Words in reg. 49(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(9)(e)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F425 Words in reg. 49(3)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(9)(e)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F426 Words in reg. 49(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(9)(f) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F427 Words in reg. 50 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(10)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F428 Words in reg. 50(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(10)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F429 Words in reg. 50(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(10)(c)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F430 Words in reg. 50(2)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(10)(c)(Ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F431 Words in reg. 50(3)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(10)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F432 Words in reg. 50(3)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(10)(e) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F433 Words in reg. 50(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(10)(f) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F434 Words in reg. 51 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(11) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F435 Words in reg. 51 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(11) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F436 Words in reg. 52(1) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 15 omitted
F437 Words in reg. 52(1) inserted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 7 inserted
F438 Words in reg. 53 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(2) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F439 Sum in reg. 53 substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 3 substituted: England, Wales and Scotland substituted
F440 Reg. 54 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F441 Words in reg. 54(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F442 Sum in reg. 54(1)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(a)(i) substituted: England, Wales and Scotland substituted
F443 Sum in reg. 54(1)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(a)(ii) substituted: England, Wales and Scotland substituted
F444 Reg. 54(2) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(3) substituted: England, Wales and Scotland substituted
F445 Sum in reg. 54(2)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(b)(i) substituted: England, Wales and Scotland substituted
F446 Sum in reg. 54(2)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(b)(ii) substituted: England, Wales and Scotland substituted
F447 Words in reg. 54(3) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 16 substituted
F448 Words in reg. 54(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F449 Reg. 54(3)(a)-(c) substituted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(2)(c) substituted
F450 Sum in reg. 54(3)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(c)(i) substituted: England, Wales and Scotland substituted
F451 Reg. 54(3)(b) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(4)(b) substituted: England, Wales and Scotland substituted
F452 Sum in reg. 54(3)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(c)(ii) substituted: England, Wales and Scotland substituted
F453 Sum in reg. 54(3)(c) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(c)(iii) substituted: England, Wales and Scotland substituted
F454 Reg. 54(3A)(3B) inserted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(2)(d) inserted
F455 Sum in reg. 54(3A)(a)(i) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(d)(i) substituted: England, Wales and Scotland substituted
F456 Sum in reg. 54(3A)(a)(ii) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(d)(ii) substituted: England, Wales and Scotland substituted
F457 Reg. 54(3C)-(3E) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(6) inserted
F458 Words in reg. 54(3C) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F459 Sum in reg. 54(3C)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(e)(i) substituted: England, Wales and Scotland substituted
F460 Sum in reg. 54(3C)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(e)(ii) substituted: England, Wales and Scotland substituted
F461 Words in reg. 54(3C) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(6)(c) inserted: England, Wales and Scotland inserted
F462 Words in reg. 54(3D) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(e)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F463 Words in reg. 54(3D) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(e)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F464 Sum in reg. 54(3D)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(f)(i) substituted: England, Wales and Scotland substituted
F465 Sum in reg. 54(3D)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(f)(ii) substituted: England, Wales and Scotland substituted
F466 Words in reg. 54(3D) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(7)(c) inserted: England, Wales and Scotland inserted
F467 Words in reg. 54(3E) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(f) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F468 Sum in reg. 54(3E) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(g) substituted: England, Wales and Scotland substituted
F469 Reg. 54(3F) inserted (E.W.S) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(9) inserted
F470 Sum in reg. 54(3F) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(h) substituted: England, Wales and Scotland substituted
F471 Words in reg. 54(4)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(i) substituted
F472 Words in reg. 54(4)(a) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(ii) inserted
F473 Words in reg. 54(4)(a)(i) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii) inserted
F474 Words in reg. 54(4)(a)(ii) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii) inserted
F475 Words in reg. 54(4)(b) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(b) inserted
F476 Reg. 54(5) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(10) substituted: England, Wales and Scotland substituted
F477 Word in reg. 55 heading omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4)(a) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F478 Words in reg. 55(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4)(b) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F479 Sum in reg. 55(1)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(a)(i) substituted: England, Wales and Scotland substituted
F480 Sum in reg. 55(1)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(a)(ii) substituted: England, Wales and Scotland substituted
F481 Reg. 55(2) substituted (E.W.S) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 11(3) substituted
F482 Sum in reg. 55(2)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(b)(i) substituted: England, Wales and Scotland substituted
F483 Sum in reg. 55(2)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(b)(ii) substituted: England, Wales and Scotland substituted
F484 Words in reg. 55(3) inserted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(c)(i) inserted
F485 Words in reg. 55(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4)(c)(i) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F486 Words in reg. 55(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4)(c)(Ii) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F487 Reg. 55(3)(a)-(d) substituted for reg. 55(3)(a)-(c) (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(c)(ii) substituted
F488 Sum in reg. 55(3)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(c)(i) substituted: England, Wales and Scotland substituted
F489 Sum in reg. 55(3)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(c)(ii) substituted: England, Wales and Scotland substituted
F490 Sum in reg. 55(3)(c) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(c)(iii) substituted
F491 Sum in reg. 55(3)(d) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(c)(ii) substituted: England, Wales and Scotland substituted
F492 Reg. 55(3A)-(3D) inserted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(d) inserted
F493 Sum in reg. 55(3A) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(d) substituted: England, Wales and Scotland substituted
F494 Sums in reg. 55(3A) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(d) substituted
F495 Sum in reg. 55(3B) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(e) substituted: England, Wales and Scotland substituted
F496 Sums in reg. 55(3B) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(e) substituted
F497 Sum in reg. 55(3C) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(f) substituted
F498 Sum in reg. 55(3D)(a)(i) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(f)(i) substituted: England, Wales and Scotland substituted
F499 Sum in reg. 55(3D)(a)(ii) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(f)(ii) substituted: England, Wales and Scotland substituted
F500 Sum in reg. 56(1)(a)(i) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(a)(i) substituted: England, Wales and Scotland substituted
F501 Sum in reg. 56(1)(a)(ii) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(a)(ii) substituted: England, Wales and Scotland substituted
F502 Sum in reg. 56(1)(b)(i) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(a)(iii) substituted: England, Wales and Scotland substituted
F503 Sum in reg. 56(1)(b)(ii) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(a)(iv) substituted: England, Wales and Scotland substituted
F504 Words in reg. 56(2) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(2) inserted
F505 Words in reg. 56(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4A) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 49); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F506 Reg. 56(3A) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(3) inserted
F507 Sum in reg. 56(3A)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(b)(i) substituted: England, Wales and Scotland substituted
F508 Sum in reg. 56(3A)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(b)(ii) substituted: England, Wales and Scotland substituted
F509 Reg. 56(3B) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 13(2) inserted: England, Wales and Scotland inserted
F510 Sum in reg. 56(3B)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(c)(i) substituted: England, Wales and Scotland substituted
F511 Sum in reg. 56(3B)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(c)(ii) substituted: England, Wales and Scotland substituted
F512 Reg. 56A inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 9 inserted
F513 Reg. 56B inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 14 inserted: England, Wales and Scotland inserted
F514 Reg. 56C inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 15 inserted: England, Wales and Scotland inserted
F515 Sum in reg. 56C(1)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(a)(i) substituted
F516 Sum in reg. 56C(1)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(a)(ii) substituted
F517 Sum in reg. 56C(2)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(b)(i) substituted
F518 Sum in reg. 56C(2)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(b)(ii) substituted
F519 Sum in reg. 56C(3)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(c)(i) substituted
F520 Sum in reg. 56C(3)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(c)(ii) substituted
F521 Reg. 56D omitted (16.7.2025) by virtue of The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 10 omitted
F522 Reg. 56E inserted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 11 inserted
F523 Words in reg. 58(2)(b)(i) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(5)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 50); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F524 Words in reg. 58(2)(b)(ii) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(5)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 50); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F525 Reg. 58A inserted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 12 inserted
F526 Words in reg. 59 omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 17 omitted
F527 Words in reg. 59 omitted (E.W.S.) (30.4.2021) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(2)(e), 9(2)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F528 Words in reg. 59 omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 20 omitted
F529 Reg. 60 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(3)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F530 Reg. 60(1)(2) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(3)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F531 Reg. 60(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(3)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F532 Words in reg. 60(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(3)(d)(i) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 8 and S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F533 Words in reg. 60(4) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 17(b) substituted
F534 Words in reg. 60(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(3)(d)(ii) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 8 and S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F535 Reg. 61(1A)-(1C) substituted for reg. 61(1)-(8) (26.5.2021) by Medicines and Medical Devices Act 2021 (c. 3), ss. 41(6), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F536 Reg. 62 omitted (26.5.2021) by virtue of Medicines and Medical Devices Act 2021 (c. 3), ss. 41(7)(a), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F537 Reg. 63 omitted (26.5.2021) by virtue of Medicines and Medical Devices Act 2021 (c. 3), ss. 41(7)(b), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F538 Reg. 64 omitted (26.5.2021) by virtue of Medicines and Medical Devices Act 2021 (c. 3), ss. 41(7)(c), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F539 Reg. 65 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F540 Words in reg. 65 substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 26 substituted: Northern Ireland substituted
F541 Reg. 67 inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 18 inserted
F542 Word in reg. 67 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(8) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F543 Sch. 1 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(9) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) omitted: England, Wales and Scotland omitted
F544 Sch. 1 para. 1 substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 19 substituted
F545 Sch. 2 para. 5 added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 20 added
F546 Sch. 2 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(10) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1) substituted: England, Wales and Scotland substituted
F547 Sch. 2A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 12 (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 56, 57); 2020 c. 1, Sch. 5 para. 1(1) inserted: England, Wales and Scotland inserted
F548 Sch. 2A para. 2(za) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(a) inserted
F549 Sch. 2A para. 2(c)(iii) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(b) inserted
F550 Words in Sch. 2A para. 3(e)(iii) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(c)(i) inserted
F551 Sch. 2A para. 3(e)(iv) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(c)(ii) inserted
F552 Sch. 2A para. 3(f)(ii) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(2) (with reg. 6) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F553 Sch. 2A para. 3(g) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(c)(iii) substituted
F554 Sch. 2A para. 3(h) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(c)(iv) substituted
F555 Words in Sch. 2A para. 5 omitted (17.6.2025) by virtue of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(3) (with reg. 6) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F556 Words in Sch. 2A para. 6 omitted (17.6.2025) by virtue of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(4) (with reg. 6) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F557 Sch. 2A para. 7(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(5) (with reg. 6) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F558 Sch. 2A para. 8 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(d) substituted
F559 Sch. 2A para. 9(aa) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(e) inserted
F560 Sch. 2A para. 13(da) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(f)(i) inserted
F561 Sch. 2A para. 13(da)(iii) omitted (17.6.2025) by virtue of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(6)(a) (with reg. 6) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F562 Sch. 2A para. 13(da)(iv) inserted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(6)(b) (with reg. 6) this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary. inserted
F563 Sch. 2A para. 15(f) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(7) (with reg. 6) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F564 Sch. 2A para. 15(zj) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(g)(i) inserted
F565 Sch. 2A para. 15(j)(ia) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(g)(ii) inserted
F566 Sch. 2A para. 16(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(8) (with reg. 6) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F567 Sch. 2A para. 17(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(9) (with reg. 6) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F568 Sch. 2A para. 17(ga) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(h)(ii) inserted
F569 Sch. 2A para. 17(k) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(h)(iii) inserted
F570 Sch. 2A para. 18(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(10) (with reg. 6) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F571 Sch. 2A para. 19(f) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(11) (with reg. 6) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F572 Words in Sch. 2A para. 22(d) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(i) substituted
F573 Sch. 2A para. 26(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(12) (with reg. 6) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F574 Sch. 2A para. 27(d)(iii) inserted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(13) (with reg. 6) this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary. inserted
F575 Sch. 2A para. 29(da) inserted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(14) (with reg. 6) this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary. inserted
F576 Words in reg. 2(1) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 2(a) omitted
F577 Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(a) omitted
F578 Words in reg. 2 substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 2(a) substituted: Northern Ireland substituted
F579 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 4 (with art. 3(3)) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F580 Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(c) inserted
F581 Words in reg. 2(1) substituted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(a)(i) substituted
F582 Words in reg. 2(1) substituted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(a)(ii) substituted
F583 Words in reg. 2(1) substituted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(a)(iii) substituted
F584 OJ No. L 311, 28.11.2001, p.67.
F585 Words in reg. 2(1) inserted (30.10.2005) by The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), reg. 1(a), Sch. para. 10 inserted
F586 Words in reg. 2(1) inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 2(c) inserted
F587 Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(b) omitted
F588 Words in reg. 2(1) inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 2(a) inserted
F589 Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(d) inserted
F590 Word in reg. 2 omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 2(b) omitted: Northern Ireland omitted
F591 Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(c) omitted
F592 Words in reg. 2(1) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(3) substituted
F593 OJ No. L 204, 21.7.1998, p.37; amended by Directive 98/48/EC (OJ No. L 217, 5.8.1998, p.18).
F594 Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(e) inserted
F595 Words in reg. 2(1) inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 2(b) inserted
F596 Words in reg. 2(1) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(f) substituted
F597 Words in reg. 2 substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 2(c) substituted: Northern Ireland substituted
F598 Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(g) inserted
F599 Words in reg. 2(1) substituted (N.I.) (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 30(a) substituted: Northern Ireland substituted
F600 Words in reg. 2(1) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(4) substituted
F601 Words in reg. 2(1) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(i) omitted
F602 Words in reg. 2 substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 2(d) substituted: Northern Ireland substituted
F603 Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(d) omitted
F604 Words in reg. 2(1) substituted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 2(f) substituted
F605 Words in reg. 2 substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 2(e) substituted: Northern Ireland substituted
F606 Words in reg. 2 substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 2(f) substituted: Northern Ireland substituted
F607 Words in reg. 2(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(5) inserted
F608 Words in reg. 2(1) inserted (N.I.) (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 30(b) inserted: Northern Ireland inserted
F609 Words in reg. 2(1) inserted (N.I.) (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 10 inserted: Northern Ireland inserted
F610 Words in reg. 2 inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 2(g) inserted: Northern Ireland inserted
F611 Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(e) omitted
F612 Reg. 2(1A) inserted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(b) inserted
F613 Reg. 2(1B) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(6) inserted
F614 Words in reg. 3(c) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(a) substituted
F615 Words in reg. 3(d) inserted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(b) inserted
F616 Words in reg. 3(d) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(a) omitted
F617 Words in reg. 3(d) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(b) inserted
F618 Reg. 3(e) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(c) substituted
F619 Words in reg. 3(e)(ii) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(c) omitted
F620 OJ No. L 262, 27.9.1976, p.169.
F621 Council Directive 76/768/EEC was amended for the twenty-sixth time by Commission Directive 2000/41/EC (OJ No. L 145, 20.6.2000, p.25).
F622 Reg. 3(g) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(d) omitted
F623 Words in reg. 7 inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 5 inserted
F624 Words in reg. 7 inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 5 inserted
F625 Words in reg. 8(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3 inserted
F626 Words in reg. 8(2) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3 inserted
F627 Reg. 8(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 5 added
F628 Reg. 9(5A) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 6(a) inserted
F629 Reg. 9(9) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 6(b) inserted
F630 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 4 (with art. 3(3)) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F631 Word in reg. 13(4)(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(a) omitted
F632 Word in reg. 13(4)(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(b) added
F633 Reg. 13(4)(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(c) added
F634 Reg. 13(5)(6) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(3) omitted
F635 Reg. 14(4)(a) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 7(a) substituted
F636 Reg. 14(4A) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 7(b) inserted
F637 Words in reg. 15(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 5 inserted
F638 Word in reg. 15(c) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 8(1) omitted
F639 Reg. 15(e) and word inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 8(2) inserted
F640 Words in reg. 16(1) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 4 substituted: Northern Ireland substituted
F641 Words in reg. 16(1)(a) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 9(a) substituted
F642 Words in reg. 16(1)(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 6 inserted
F643 Reg. 16(11) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 9(b) added
F644 Reg. 17(3) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 5 omitted: Northern Ireland omitted
F645 Reg. 17(4)(5) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 7 omitted
F646 Words in reg. 18(1)(b) substituted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 8 substituted
F647 Words in reg. 18(2) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 10 substituted
F648 Reg. 18(4) added (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 8 added
F649 Reg. 21 renumbered as reg. 21(1) (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(a) renumbered
F650 Reg. 21(2)(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(b) added
F651 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 4 (with art. 3(3)) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F652 Word in reg. 27(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(a) omitted
F653 Word in reg. 27(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(b) added
F654 Reg. 27(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(c) added
F655 Words in reg. 28(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 12 inserted
F656 Words in reg. 29(1) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 10 substituted: Northern Ireland substituted
F657 Words in reg. 29(1)(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 13 inserted
F658 Reg. 29(10) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 13 added
F659 Reg. 30(3)-(5) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 14 added
F660 Words in reg. 30(4) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 11(a) substituted: Northern Ireland substituted
F661 Words in reg. 30(5) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 11(b) substituted: Northern Ireland substituted
F662 Words in reg. 31(2) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 15 substituted
F663 Words in reg. 32(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 11 omitted
F664 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 4 (with art. 3(3)) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F665 Words in reg. 35(2) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 12 substituted: Northern Ireland substituted
F666 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 4 (with art. 3(3)) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F667 Words in reg. 41(5) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 14 substituted: Northern Ireland substituted
F668 Words in reg. 45(1) inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 16 inserted: Northern Ireland inserted
F669 Words in reg. 45(2)(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(2) inserted
F670 Words in reg. 45(2)(b) inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 13(a) inserted
F671 Words in reg. 45(2)(b) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(3) substituted
F672 Words in reg. 45(5)(b) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(4) substituted
F673 Words in reg. 45(7) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(4) substituted
F674 Words in reg. 45(8) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(4) substituted
F675 Words in reg. 47(4)(5) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 16 omitted
F676 Reg. 47(9)(10) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 15 omitted
F677 Reg. 47A inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 17 inserted: Northern Ireland inserted
F678 Word in reg. 48 heading omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(a) omitted: Northern Ireland omitted
F679 Words in reg. 48(1) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(b)(i) substituted: Northern Ireland substituted
F680 Words in reg. 48(1) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(b)(ii) omitted: Northern Ireland omitted
F681 Words in reg. 48(1) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(b)(iii) substituted: Northern Ireland substituted
F682 Words in reg. 48(2) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(c)(i) substituted: Northern Ireland substituted
F683 Words in reg. 48(2) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(c)(ii) substituted: Northern Ireland substituted
F684 Words in reg. 48(4) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(d) substituted: Northern Ireland substituted
F685 Words in reg. 48(5) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(e)(i) substituted: Northern Ireland substituted
F686 Words in reg. 48(5) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(e)(ii) substituted: Northern Ireland substituted
F687 Words in reg. 48(6) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(f) omitted: Northern Ireland omitted
F688 Words in reg. 48(7) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(g)(i) substituted: Northern Ireland substituted
F689 Words in reg. 48(7) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(g)(ii) substituted: Northern Ireland substituted
F690 Words in reg. 48(8) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(h)(i) substituted: Northern Ireland substituted
F691 Words in reg. 48(8) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(h)(ii) substituted: Northern Ireland substituted
F692 Reg. 49 heading substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 19(a) substituted: Northern Ireland substituted
F693 Word in reg. 49(1) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 19(b) substituted: Northern Ireland substituted
F694 Words in reg. 49(1)(a) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 19(c) substituted: Northern Ireland substituted
F695 Words in reg. 49(1)(b) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 19(d)(i) substituted: Northern Ireland substituted
F696 Words in reg. 49(1)(b) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 19(d)(ii) substituted: Northern Ireland substituted
F697 Word in reg. 49(3) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 19(e) substituted: Northern Ireland substituted
F698 Word in reg. 49(4) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 19(f) substituted: Northern Ireland substituted
F699 Word in reg. 53 inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 20 inserted: Northern Ireland inserted
F700 Sum in reg. 53 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 4 substituted
F701 Sum in reg. 54(1)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(2)(a) substituted
F702 Sum in reg. 54(1)(b) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(2)(b) substituted
F703 Sum in reg. 54(2) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(3) substituted
F704 Words in reg. 54(3) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 16 substituted
F705 Reg. 54(3)(a)-(c) substituted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(2)(c) substituted
F706 Sum in reg. 54(3)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(4)(a) substituted
F707 Sum in reg. 54(3)(b) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(4)(b) substituted
F708 Sum in reg. 54(3)(c) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(4)(c) substituted
F709 Reg. 54(3A)(3B) inserted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(2)(d) inserted
F710 Sum in reg. 54(3A)(a)(i) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(5)(a) substituted
F711 Sum in reg. 54(3A)(a)(ii) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(5)(b) substituted
F712 Reg. 54(3C)-(3E) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(6) inserted
F713 Words in reg. 54(4)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(i) substituted
F714 Words in reg. 54(4)(a) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(ii) inserted
F715 Words in reg. 54(4)(a)(i) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii) inserted
F716 Words in reg. 54(4)(a)(ii) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii) inserted
F717 Words in reg. 54(4)(b) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(b) inserted
F718 Reg. 54(5) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(8) inserted
F719 Word in reg. 55 heading omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 21(a) omitted: Northern Ireland omitted
F720 Words in reg. 55(1) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 21(b) substituted: Northern Ireland substituted
F721 Sum in reg. 55(1)(a) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(a)(i) substituted: Northern Ireland substituted
F722 Sum in reg. 55(1)(b) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(a)(ii) substituted: Northern Ireland substituted
F723 Reg. 55(2) substituted (N.I.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 12(3) substituted: Northern Ireland substituted
F724 Sum in reg. 55(2)(a) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(b)(i) substituted: Northern Ireland substituted
F725 Sum in reg. 55(2)(b) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(b)(ii) substituted: Northern Ireland substituted
F726 Words in reg. 55(3) inserted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(c)(i) inserted
F727 Words in reg. 55(3) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 21(c)(i) substituted: Northern Ireland substituted
F728 Words in reg. 55(3) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 21(c)(ii) substituted: Northern Ireland substituted
F729 Reg. 55(3)(a)-(d) substituted for reg. 55(3)(a)-(c) (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(c)(ii) substituted
F730 Sum in reg. 55(3)(a) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(c)(i) substituted: Northern Ireland substituted
F731 Sum in reg. 55(3)(b) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(c)(ii) substituted: Northern Ireland substituted
F732 Sum in reg. 55(3)(c) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(c)(iii) substituted
F733 Sum in reg. 55(3)(d) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(c)(ii) substituted: Northern Ireland substituted
F734 Reg. 55(3A)-(3D) inserted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(d) inserted
F735 Sum in reg. 55(3A) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(d) substituted: Northern Ireland substituted
F736 Sums in reg. 55(3A) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(d) substituted
F737 Sum in reg. 55(3B) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(e) substituted: Northern Ireland substituted
F738 Sums in reg. 55(3B) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(e) substituted
F739 Sum in reg. 55(3C) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(f) substituted
F740 Sum in reg. 55(3D)(a)(i) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(f)(i) substituted: Northern Ireland substituted
F741 Sum in reg. 55(3D)(a)(ii) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(f)(ii) substituted: Northern Ireland substituted
F742 Sums in reg. 56(1)(a) substituted (1.4.2013) by The Medical Devices (Fees Amendment) Regulations 2013 (S.I. 2013/525), regs. 1, 2(2)(a) substituted
F743 Sums in reg. 56(1)(b) substituted (1.4.2013) by The Medical Devices (Fees Amendment) Regulations 2013 (S.I. 2013/525), regs. 1, 2(2)(b) substituted
F744 Words in reg. 56(2) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(2) inserted
F745 Reg. 56(3A) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(3) inserted
F746 Words in reg. 58(2)(b)(ii) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 22 substituted: Northern Ireland substituted
F747 Words in reg. 60(1) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(a)(i) omitted: Northern Ireland omitted
F748 Words in reg. 60(1) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(a)(ii) substituted: Northern Ireland substituted
F749 Words in reg. 60(1)(2)(3) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 17(a) substituted
F750 Words in reg. 60(2) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(b)(i) substituted: Northern Ireland substituted
F751 Words in reg. 60(2) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(b)(ii) substituted: Northern Ireland substituted
F752 Words in reg. 60(3) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(c)(i) substituted: Northern Ireland substituted
F753 Words in reg. 60(3)(b) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(c)(ii)(aa) substituted: Northern Ireland substituted
F754 Words in reg. 60(3)(b) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(c)(ii)(bb) substituted: Northern Ireland substituted
F755 Words in reg. 60(4) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 17(b) substituted
F756 Words in reg. 61(1) revoked (20.6.2003) by The Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Amendment and Specification) Order 2003 (S.I. 2003/1400), art. 1, Sch. 5
F757 See section s 11(1) and 45(1) of that Act.
F758 Reg. 61(1A) inserted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(a) inserted: Northern Ireland inserted
F759 Words in reg. 61(2) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(b) omitted: Northern Ireland omitted
F760 Words in reg. 61(3) omitted (22.11.2005) by virtue of The Medical Devices (Amendment) Regulations 2005 (S.I. 2005/2909), regs. 1, 2(a) omitted
F761 Words in reg. 61(3) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(c) omitted: Northern Ireland omitted
F762 Words in reg. 61(5) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(d) omitted: Northern Ireland omitted
F763 Reg. 61(6) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 6 substituted
F764 Reg. 61(6)(a) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(e) omitted: Northern Ireland omitted
F765 Reg. 61(6)(c) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 24(e) omitted: Northern Ireland omitted
F766 Reg. 61(7A) inserted (22.11.2005) by The Medical Devices (Amendment) Regulations 2005 (S.I. 2005/2909), regs. 1, 2(b) inserted
F767 Words in reg. 61(8)(a)(i) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 17 inserted
F768 Reg. 67 inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 18 inserted
M1 1972 c. 68.
M2 The Secretary of State was designated in relation to measures relating to active implantable medical devices in S.I. 1991/2289, and in relation to measures relating to medical devices other than active implantable medical devices in S.I. 1993/2661.
M3 1973 c. 51.
M4 1987 c. 43.
M5 S.I. 1993/2360.
M6 Council of Europe (ETS No. 164), Orviedo, 4.4.1997.
M7 S.I. 1992/3146.
M8 S.I. 1994/3017.
M9 S.I. 1995/1671.
M10 S.I. 1995/2487.
M11 S.I. 1997/694.
M12 S.I. 2000/1315.
M13 S.I. 2002/236.
M14 OJ No. L 229, 17.8.1998, p.3.
M15 OJ No. L 229, 17.8.1998, p.62.
M16 OJ No. L 280, 16.10.1998, p.3.
M17 OJ No. L 31, 4.2.1999, p.3.
M18 Council of Europe (ETS No. 164), Orviedo, 4.4.1997.
M19 See section 45(1) of that Act.
Defined Term Section/Article ID Scope of Application
a devolved public health body reg. 34B. of PART IV def_4d889ed0a3
a health service body reg. 34B. of PART IV def_eeb3ce631e
accessory reg. 32. of PART IV def_5455ed8c6d
accessory reg. 32. of PART IV def_2f540b7577
accessory reg. 4T. of PART I def_65ed5e596a
accessory reg. 4T. of PART I def_510156af7a
accessory reg. 4T. of PART I def_2ea317e0ef
accessory reg. 4T. of PART I def_c45be39c6d
accessory reg. 5. of PART II def_6c0bf924ff
active implantable medical device reg. 2. of PART I def_878fd27253
active implantable medical device reg. 2. of PART I def_40a777e59b
active implantable medical device reg. 4T. of PART I def_dde657897b
an existing contract reg. 34B. of PART IV def_207a70f668
antigen test reg. 38B. of PART IV def_fbcb305432
any preventive or corrective action reg. 44ZL. of PART 4A def_e131474292
any preventive or corrective action reg. 44ZM. of PART 4A def_1241288426
approved body reg. 2. of PART I def_e2100f91d4
approved body reg. 45. of PART V def_d77b0ddf83
approved manufacturer reg. 52. of PART VI def_02a8b61439
Association Agreement reg. 2. of PART I def_2110037715
authorised medicinal product reg. 52. of PART VI def_3593ea1993
authorised representative reg. 2. of PART I def_9ef6af986f
CAB reg. 2. of PART I def_9aa3c4d6a5
CAB reg. 2. of PART I def_978930de94
CAB reg. 48. of PART V def_339b2c3e79
CAB reg. 48. of PART V def_75fafa72c2
calibration and control material reg. 32. of PART IV def_a3b4086353
calibration and control material reg. 32. of PART IV def_074d9ec4e5
CE reg. 2. of PART I def_49ad6d9072
CE reg. 2. of PART I def_47d3c148b9
CE marking reg. 19B. of PART II def_fec040b020
CE marking reg. 19B. of PART II def_02d5b590f3
CE marking reg. 19C. of PART II def_73936edeff
CE marking reg. 19C. of PART II def_3a3ec7559e
CE marking reg. 2. of PART I def_c0e9b811c8
CE marking reg. 2. of PART I def_ac46cc01b6
CE marking reg. 30A. of PART III def_53a35e379c
CE marking reg. 30A. of PART III def_f72d6024b5
CE marking reg. 44ZA of PART IV def_0a47a1dd5e
CE marking reg. 44ZA of PART IV def_dcc791df7a
CE marking reg. 44ZB. of PART IV def_eb78124be7
CE marking reg. 44ZB. of PART IV def_7698ebea7f
clinical data reg. 2. of PART I def_fa36ebdbbd
clinical data reg. 2. of PART I def_637165ed81
clinical development reg. 52. of PART VI def_f826299900
common technical specification reg. 32. of PART IV def_bf10ff90c4
common technical specification reg. 32. of PART IV def_07276ac575
consultation reg. 52. of PART VI def_32a389bee8
consumer goods reg. 61. of PART VII def_fcb9b21114
coronavirus test device reg. 2. of PART I def_75dd25ba6c
coronavirus test device reg. 2. of PART I def_54f5fb90c4
corrective action reg. 44ZC. of PART 4A def_a47cff96d6
custom-made device reg. 20. of PART III def_c3251b0e4a
custom-made device reg. 44ZD. of PART 4A def_1c8a9a1884
custom-made device reg. 5. of PART II def_3e196aee66
declaration of conformity reg. 21A. of PART III def_d5615b2754
declaration of conformity reg. 33A. of PART IV def_4ff8f79a28
declaration of conformity reg. 7A. of PART II def_ec45800c15
designated standard reg. 2. of PART I def_1efe0a5687
designated standard reg. 3A. of PART I def_06c2180feb
device reg. 3A. of PART I def_e1f4da5f1f
device for performance evaluation reg. 2. of PART I def_c3f137129e
device for performance evaluation reg. 2. of PART I def_6ec0621acd
device for self-testing reg. 32. of PART IV def_658e888f69
device for self-testing reg. 32. of PART IV def_fb2b8fb4ce
devices reg. 44ZD. of PART 4A def_ca726bc3d3
direct molecular test reg. 38B. of PART IV def_8f2b2311cf
Directive 2001/83 reg. 2. of PART I def_895edd7adb
Directive 2003/12 reg. 2. of PART I def_38430aacd6
Directive 2003/12 reg. 2. of PART I def_2e386c2505
Directive 2005/50 reg. 2. of PART I def_8cffa090d9
Directive 2005/50 reg. 2. of PART I def_824eac44a0
Directive 2007/47 reg. 2. of PART I def_50994dce38
Directive 2007/47 reg. 2. of PART I def_5f5ee6727b
Directive 90/385 reg. 2. of PART I def_f55fb8b5f5
Directive 90/385 reg. 2. of PART I def_ca99f9ffe5
Directive 93/42 reg. 2. of PART I def_757d79292a
Directive 93/42 reg. 2. of PART I def_b109947c70
Directive 93/42/EEC reg. 4T. of PART I def_070ccc4b92
Directive 98/79 reg. 2. of PART I def_8b773f70c1
Directive 98/79 reg. 2. of PART I def_597926bd21
European Economic Area reg. 2. of PART I def_0e3494db56
examination certificate reg. 52. of PART VI def_77013787a9
extracted molecular test reg. 38B. of PART IV def_777d60e94e
field safety corrective action reg. 44ZC. of PART 4A def_332bc90ddf
FSCA reg. 44ZJ. of PART 4A def_374a7a07fe
FSCA reg. 44ZK. of PART 4A def_385eb8416f
further consultation reg. 52. of PART VI def_2fdd4817d5
Group A device reg. 52. of PART VI def_51ed3b5aa3
Group B device reg. 52. of PART VI def_a7c8869919
half day reg. 52. of PART VI def_8c5623cdcc
harmonised standard reg. 19B. of PART II def_65685649ab
harmonised standard reg. 19C. of PART II def_f65524550e
harmonised standard reg. 2. of PART I def_04d9f5e556
harmonised standard reg. 30A. of PART III def_0c48f08f28
harmonised standard reg. 44ZA of PART IV def_871119c9d0
harmonised standard reg. 44ZB. of PART IV def_45f16e3c11
hazard reg. 2. of PART I def_8a7f7c1fe9
hazard reg. 2. of PART I def_c6fd83317a
hip, knee or shoulder replacement reg. 2. of PART I def_3c59d77335
hip, knee or shoulder replacement reg. 2. of PART I def_490df8a548
in vitro diagnostic medical device reg. 2. of PART I def_ef35f4b466
in vitro diagnostic medical device reg. 2. of PART I def_2900650500
in vitro diagnostic medical device reg. 4T. of PART I def_b8b7b19b7a
incident reg. 44ZC. of PART 4A def_32c928cd30
incorporates reg. 52. of PART VI def_07a373086d
intended for clinical investigation reg. 2. of PART I def_4a8737a080
intended for clinical investigation reg. 2. of PART I def_92a8248993
intended purpose reg. 2. of PART I def_155d4b4406
intended purpose reg. 2. of PART I def_72673308ca
international standardising body reg. 3A. of PART I def_a7667c0bbe
lifetime of a device reg. 44ZC. of PART 4A def_a59d6591f3
machinery reg. 2. of PART I def_9232490798
machinery reg. 2. of PART I def_f2733a0ffb
manufacturer reg. 2. of PART I def_cb5faa0054
manufacturer reg. 2. of PART I def_48452d9938
marketing authorisation reg. 52. of PART VI def_3c66b10d24
medical device reg. 2. of PART I def_b0e57b80d6
medical device reg. 2. of PART I def_c423884622
medical device reg. 44A. of PART V def_bf0bd07e3c
medical device reg. 4T. of PART I def_632102d337
medical device reg. 4T. of PART I def_d76ec6f98b
medicinal product reg. 2. of PART I def_82b41e18f7
medicinal product reg. 2. of PART I def_ff3c9fbc8d
medicinal substance reg. 52. of PART VI def_a60b66443b
mutual recognition agreement reg. 2. of PART I def_1778bc775c
Mutual Recognition Agreements reg. 2. of PART I def_1c9fe116ce
national standard reg. 2. of PART I def_faabfcaf6a
new medicinal substance reg. 52. of PART VI def_cf7575ba54
new relevant device reg. 33A. of PART IV def_b31cec0872
new relevant device reg. 44. of PART IV def_0272089c7f
non-conforming devices reg. 61. of PART VII def_77fdb552e2
notified body reg. 2. of PART I def_54b7f07ce7
paragraph 4.3 of Annex II to Directive 93/42/EEC reg. 4T. of PART I def_507d40ef64
paragraph 5 of Annex III to Directive 93/42/EEC reg. 4T. of PART I def_e435991a6f
persons associated with it reg. 56A. of PART VI def_a49233519f
placing on the market reg. 2. of PART I def_0b1f4aa7e1
placing on the market reg. 2. of PART I def_52e0ec85bd
PMS period reg. 44ZC. of PART 4A def_cd27d11145
PMS plan reg. 44ZF. of PART 4A def_a8421004a7
PMS system reg. 44ZE. of PART 4A def_051973593e
PMSR reg. 44ZL. of PART 4A def_07f4e3dc94
post-market surveillance reg. 44ZC. of PART 4A def_b4f68e8d0d
preventive action reg. 44ZC. of PART 4A def_bf0d0d3b3a
PSUR reg. 44ZM. of PART 4A def_06ec618981
putting into service reg. 2. of PART I def_dedca7c6ce
putting into service reg. 2. of PART I def_7a8dcb13ad
qualifying Northern Ireland good reg. 2A. of PART I def_8d760a9859
quality development reg. 52. of PART VI def_5d27be45ac
recognised standardisation body reg. 3A. of PART I def_9a4707f160
registrable device reg. 59. of PART VII def_f4f9375906
Regulation (EU) 2017/745 reg. 2. of PART I def_23374ff84e
Regulation (EU) 2017/745 reg. 2. of PART I def_c087c1d129
Regulation (EU) 2017/745 reg. 2A. of PART I def_4c8a03cfc2
Regulation (EU) 2017/746 reg. 2. of PART I def_40053828a5
Regulation (EU) 2017/746 reg. 2. of PART I def_bc1972172c
Regulation (EU) 2022/1107 reg. 2. of PART I def_8184c90fe9
Regulation (EU) 2022/1107 reg. 2. of PART I def_7f907c5deb
Regulation (EU) No 722/2012 reg. 2. of PART I def_5b9cecefa7
Regulation (EU) No 722/2012 reg. 44ZC. of PART 4A def_c5f9790e4b
Regulation (EU) No 920/2013 reg. 54. of PART VI def_bf4d322e37
Regulation 722/2012 reg. 19B. of PART II def_f56518a402
Regulation 722/2012 reg. 30A. of PART III def_6bebabec56
Regulation 722/2012 reg. 44ZA of PART IV def_d64d76bf1f
relevant device reg. 20. of PART III def_324af4c589
relevant device reg. 32. of PART IV def_b5bf3524a8
relevant device reg. 32. of PART IV def_9e9c3d5394
relevant device reg. 44A. of PART V def_0578195ebc
relevant device reg. 44ZC. of PART 4A def_0c62ee99e9
relevant device reg. 44ZC. of PART 4A def_206ecc50ec
relevant device reg. 5. of PART II def_6bef39268f
relevant device reg. 59. of PART VII def_f55e0f04d3
relevant device reg. 59. of PART VII def_b4d232fc6b
relevant essential requirements reg. 2. of PART I def_56523586c1
relevant essential requirements reg. 2. of PART I def_498e135056
relevant essential requirements reg. 44ZC. of PART 4A def_b325631db3
relevant information reg. 33A. of PART IV def_8b57b590c5
relevant information reg. 44. of PART IV def_37c2694672
relevant market reg. 2. of PART I def_813051bde3
relevant period reg. 52. of PART VI def_f4e5f0ee5d
relevant state reg. 2. of PART I def_8069e2311c
required risk analysis reg. 44ZC. of PART 4A def_7ecc7b57ff
safety development reg. 52. of PART VI def_ee6dee9f35
scientific advice reg. 52. of PART VI def_f741d3b27b
sensitivity reg. 38B. of PART IV def_c1b889d726
serious deterioration of any person’s state of health reg. 44ZC. of PART 4A def_e5a735763c
serious incident reg. 44ZC. of PART 4A def_60865ecf9f
serious public health threat reg. 44ZC. of PART 4A def_a2e0820eda
similar device reg. 44ZC. of PART 4A def_61072901b8
single-use combination product reg. 5. of PART II def_66668faf31
specificity reg. 38B. of PART IV def_8c3dc5dd23
specimen receptacle reg. 2. of PART I def_035b281c0c
specimen receptacle reg. 2. of PART I def_c3d32c8f18
sponsor reg. 19C. of PART II def_c3cbcba2e2
sponsor reg. 44ZB. of PART IV def_326684f1d8
stable derivatives device reg. 2. of PART I def_ac8a616b0c
stable derivatives device reg. 2. of PART I def_b868595973
State which is a Party to an Association Agreement reg. 2. of PART I def_8bf260048b
statistical review reg. 2. of PART I def_e43b541bfe
subsidiary reg. 54. of PART VI def_411957f815
supply reg. 2. of PART I def_82bcdc9b3b
supply reg. 2. of PART I def_0b01546a2e
system or procedure pack reg. 44ZC. of PART 4A def_f534db50b4
system or procedure pack reg. 5. of PART II def_eef43f98b3
technical documentation reg. 21A. of PART III def_347697868e
technical documentation reg. 33A. of PART IV def_24f88f4b2d
technical documentation reg. 7A. of PART II def_51d7b032e8
technical specification reg. 3A. of PART I def_50a32ee5bc
the Community reg. 2. of PART I def_c22cc95941
the Directive reg. 19B. of PART II def_330e333531
the Directive reg. 30A. of PART III def_14ea148cf7
the European Pharmacopoeia reg. 3A. of PART I def_b0a2300703
the Medical Devices Directives reg. 2. of PART I def_3e7ce11685
the Medical Devices Directives reg. 2. of PART I def_9f5e44df04
the other Directive reg. 11. of PART II def_2a17966918
the other Directive reg. 21. of PART III def_92909d34b4
the other Directive reg. 25. of PART III def_0c0aba58db
the other Directive reg. 33. of PART IV def_39b5d0b753
the other Directive reg. 33. of PART IV def_08321816ab
the other Directive reg. 37. of PART IV def_2287b9d0d3
the other Directive reg. 6. of PART II def_94cbadce23
the other legislation reg. 11. of PART II def_3d33262cb6
the other legislation reg. 25. of PART III def_b660410a69
the other legislation reg. 37. of PART IV def_85f0e85115
the other standard reg. 12. of PART II def_8245e5134d
the other standard reg. 26. of PART III def_2780a9cbb1
the other standard reg. 39. of PART IV def_218c0888d7
the product reg. 3A. of PART I def_35ab7685eb
the Regulation reg. 19C. of PART II def_2d617b5523
the Regulations para PART 1 of SCHEDULE 2A def_16345a2677
the Regulations para PART 2 of SCHEDULE 2A def_fe87d8caec
the Regulations para PART 3 of SCHEDULE 2A def_cb95979075
third country conformity assessment body reg. 2. of PART I def_53bd6861a1
third country conformity assessment body reg. 2. of PART I def_4fc102727a
UK marking reg. 19B. of PART II def_f257f59648
UK marking reg. 19C. of PART II def_ef327c2306
UK marking reg. 2. of PART I def_9064deeb27
UK marking reg. 30A. of PART III def_79d1dbcf48
UK marking reg. 44ZA of PART IV def_e252609813
UK marking reg. 44ZB. of PART IV def_72223697f4
UK mutual recognition agreement reg. 2. of PART I def_1867061953
UK notified body reg. 2. of PART I def_f72f14ef80
UK notified body reg. 45. of PART V def_6c95809d29
UK notified body reg. A45. of PART V def_d514e8079b
UK responsible person reg. 2. of PART I def_6dba978185
UK responsible person reg. 2. of PART I def_4a031bdcb4
UK(NI) indication reg. 2. of PART I def_146b8285c9
working day reg. 2. of PART I def_dac9213aec

Status of changes to instrument text

The list includes made instruments, both those in force and those yet to come into force. Typically, instruments that are not yet in force (hence their changes are not incorporated into the text above) are indicated by description 'not yet' in the changes made column.

Contains public sector information licensed under the Open Government Licence v3.0.