PART 1 Preliminary

Citation and commencement_I1

1.—(1) These Regulations may be cited as the Medical Devices (Northern Ireland Protocol) Regulations 2021.

(2) These Regulations come into force on the day after the day on which they are made.

Extent and application_I2

2.—(1) Parts 1, 4, 5, 7 and 8 extend to England and Wales, Scotland and Northern Ireland.

(2) Parts 2, [^F12A,^F1] 3 [^F2, 3A^F2] and 6 extend to Northern Ireland only.

(3) Any amendment made by Part 9 has the same extent as the provision amended.

(4) In Part 8—

(a)Regulations 30, and 32 to 37 apply in relation to Northern Ireland only;

(b)Regulation 31 applies in relation to Great Britain only.

Interpretation_I3

3.—(1) In these Regulations—

“ Regulation (EU) 2017/745 ” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5th April 2017 on medical devices, amending , Regulation Directive 2001/83/EC (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( 3 );

[^F3 “ Regulation (EU) 2017/746 ” means 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 ; ^F3]

“ethics committee” means a research ethics committee recognised or established by, or on behalf of, the Scottish Ministers, the Welsh Ministers, the Department of Health in Northern Ireland or the Health Research Authority( 4 ).

[^F4 “ Institute ” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators; ^F4]

[^F4 “ UK(NI) indication ” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 . ^F4]

[^F5 (2) Unless otherwise defined in these Regulations—

(a)terms used in Parts 2 and 3 have the same meaning as in Regulation (EU) 2017/745;

(b)terms used in Parts 2A and 3A have the same meaning as in Regulation (EU) 2017/746.^F5]

[^F6 (3) In these Regulations, a reference to an Article or an Annex is—

(a)in Parts 2 and 3, a reference to an Article or an Annex of Regulation (EU) 2017/745;

(b)in Parts 2A and 3A, a reference to an Article or an Annex of Regulation (EU) 2017/746.^F6]

[^F7Scope _I4

4. In these Regulations—

(a)Parts 4, 5 and 6 apply to all devices to which Regulation (EU) 2017/745 and Regulation (EU) 2017/746 apply;

(b)Parts 2 and 3 apply to all devices to which Regulation (EU) 2017/745 applies;

(c)Parts 2A and 3A apply to all devices to which Regulation (EU) 2017/746 applies.^F7]

PART 2 Making available on the market and putting into service under Regulation (EU) 2017/745

Reprocessing of single-use devices_I5

5. The reprocessing and further use of single-use devices is permitted only when it is carried out in accordance with Article 17.

Requirement on health institutions to provide information relating to implanted devices_I6

6. A health institution which has implanted a device to which Article 18 applies, must make available to the patient in whom the device has been implanted—

(a)the implant card for the device bearing the health institution’s identity, and

(b)the information provided by the manufacturer with the device pursuant to Article 18(1), by any means that allow rapid access to that information.

Registration of custom-made devices_I7

7.—(1) A manufacturer who makes custom-made devices available on the market in Northern Ireland must register that type of device with the Secretary of State.

(2) Registration—

(a)must take place within 28 days beginning with the day on which that type of device is first made available on the market, and

(b)requires the manufacturer to submit to the Secretary of State the information specified in paragraph (3).

(3) The information to be submitted to the Secretary of State is—

(a)the name, business address and contact details of the manufacturer of the device;

(b)if an authorised representative has been designated by the manufacturer, the authorised representative’s name, business address, contact details and evidence of that designation;

(c)a description of the type of device concerned.

(4) The manufacturer must ensure that the information submitted to the Secretary of State remains up to date.

(5) The fee payable to the Secretary of State for registering a device or amending the registration of a device under this regulation is [^F8£261^F8] .

(6) This regulation does not apply before 1st September 2021 in respect of any class IIa or class IIb non-implantable devices made available on the market by a manufacturer who is not established in the United Kingdom.

Certificates of free sale [^F9under Regulation (EU) 2017/745^F9] - fee_I8

8. A manufacturer or authorised representative who requests a certificate of free sale from the Secretary of State under Article 60(1), must pay to the Secretary of State a fee of £75.

Retention of documentation relating to conformity assessments and custom-made devices_I9

9.—(1) The liquidator or trustee in bankruptcy of a manufacturer, or of an authorised representative, must—

(a)retain for the required period any documentation that consists of, or reasonably could consist of, information to which section 8 of Annex IX applies, and

(b)comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.

(2) In this regulation, the required period is—

(a)in the case of information relating to an implantable device, 15 years after the last device was placed on the market, and

(b)in any other case, 10 years after the last device was placed on the market.

UK(NI) indication [^F10under Regulation (EU) 2017/745^F10] _I10

10.—(1) This regulation applies if the CE marking is affixed in accordance with Article 20 on the basis of a certificate issued by a notified body established in the United Kingdom.

(2) The CE marking must be accompanied by the UK(NI) indication.

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

(4) The manufacturer must affix the UK(NI) indication—

(a)visibly, legibly and indelibly, and

(b)^F11before placing the device on the market ....

^F12(5) A person may only make available on the market ... a device to which this regulation applies if the manufacturer has affixed the UK(NI) indication in accordance with this regulation.

^F13(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[^F14Part 2A Making available on the market and putting into service under Regulation (EU) 2017/746

Certificates of free sale under Regulation (EU) 2017/746 – fee

10A. A manufacturer or authorised representative who requests a certificate of free sale from the Secretary of State under Article 55 must pay to the Secretary of State a fee of £75.

Retention of documentation relating to conformity assessments

10B.—(1) The liquidator or trustee in bankruptcy of a manufacturer, or of an authorised representative, must—

(a)retain for the required period any documentation that consists of, or reasonably could consist of, information to which section 7 of Annex IX applies, and

(b)comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.

(2) In this regulation, the required period is 10 years after the last device was placed on the market.

UK(NI) indication under Regulation (EU) 2017/746

10C.—(1) This regulation applies if the CE marking is affixed in accordance with Article 18 on the basis of a certificate issued by a notified body established in the United Kingdom.

(2) The CE marking must be accompanied by the UK(NI) indication.

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

(4) The manufacturer must affix the UK(NI) indication—

(a)visibly, legibly and indelibly, and

(b)before placing the device on the market.

(5) A person may only make available on the market a device to which this regulation applies if the manufacturer has affixed the UK(NI) indication in accordance with this regulation.^F14]

PART 3 Clinical investigations under Regulation (EU) 2017/745

[^F15Legal representatives and contact persons for clinical investigations

A11.—(1) The first subparagraph of Article 62(2) (requirement to have a legal representative established in the Union) does not apply to a clinical investigation conducted in Northern Ireland if all of the following conditions are met—

(a)the clinical investigation is also being conducted in Great Britain;

(b)the clinical investigation is not also being conducted in a Member State;

(c)the sponsor—

(i)is established in Great Britain, or

(ii)has a written agreement with a legal representative established in Great Britain who is responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745;

(d)the sponsor has a contact person established in Northern Ireland in respect of the clinical investigation.

(2) A contact person referred to in this regulation must be the addressee for all communications with the sponsor provided for in Regulation (EU) 2017/745 and any communication with that contact person is deemed to be a communication with the sponsor.

(3) The agreement referred to in paragraph (1)(c)(ii) must provide for—

(a)the legal representative to be responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745,

(b)the legal representative to immediately inform the sponsor of all communications received in its capacity as the sponsor’s legal representative, and

(c)the sponsor to share with its legal representative all communications and documentation necessary to enable the legal representative to fulfil its obligations under this regulation.

(4) A legal representative referred to in paragraph (1)(c)(ii) must have a written agreement with the contact person to provide for—

(a)the contact person to immediately inform the legal representative of all communications received in its capacity as the sponsor’s contact person, and

(b)the legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

(5) Where the sponsor is established in Great Britain, the sponsor must have a written agreement with the contact person to provide for—

(a)the contact person to immediately inform the sponsor of all communications received in its capacity as the sponsor’s contact person, and

(b)the sponsor to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

(6) Where the sponsor has a legal representative established in Great Britain, the application form and the clinical investigation plan drawn up in accordance with chapter II of Annex XV must include the name, address and contact details of the legal representative established in Great Britain.^F15]

Ethical review of clinical investigations_I11

11.—(1) A sponsor proposing to conduct a clinical investigation of a device in Northern Ireland must apply to an ethics committee for an ethical review of the proposed clinical investigation.

(2) The sponsor must submit to the Secretary of State a copy of the opinion of the ethics committee as soon as it becomes available and before the clinical investigation is started.

Prior authorisation of clinical investigations by the Secretary of State_I12

12.—(1) A clinical investigation to which Article 70(7)(a) applies must not start unless—

(a)it has been authorised by the Secretary of State, and

(b)a favourable opinion in respect of the clinical investigation has been issued by an ethics committee.

(2) For the purposes of paragraph (1)(a) and subject to paragraph (3), the Secretary of State must notify the sponsor of whether the clinical investigation is authorised within—

(a)65 days of the validation date provided for in Article 70(5), if the Secretary of State decides to consult experts for advice on whether the clinical investigation should be authorised, or

(b)45 days of the validation date in any other case.

(3) If the Secretary of State requests additional information from the sponsor under Article 70(6), the expiry of the periods in paragraph (2) is suspended from the date of the first request until such time as the additional information has been received.

Arbitration following the refusal of a clinical investigation application_I13

13.—(1) A sponsor notified of a refusal under Article 70(3), 71(4), or 78(10) may, within 28 days of being notified, apply to the Institute to appoint an adjudicator to review the refusal.

(2) The adjudicator must provide a report to the Secretary of State and the sponsor setting out any recommendations in respect of the disputed refusal.

(3) The Secretary of State must take the report of the adjudicator into account and decide whether to—

(a)confirm or alter the grounds for the refusal of the application,

(b)authorise the clinical investigation, or

(c)in the case of a refusal under Article 70(3), proceed to consider the application under Article 70.

(4) The Secretary of State must notify the sponsor of the decision in paragraph (3).

(5) The sponsor must pay any fees, costs or expenses of the Institute and its appointed adjudicator that are payable in connection with the application made under paragraph (1).

^F16(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Damage compensation in relation to clinical investigations_I14

14. A sponsor of a clinical investigation must hold sufficient insurance (or equivalent financial resources) to meet any potential financial liability in the event of injury or death attributable to participation in the clinical investigation.

Retention of documentation relating to clinical investigations_I15

15.—(1) The liquidator or trustee in bankruptcy of a sponsor of a clinical investigation or of a sponsor’s legal representative or contact person under Article 62(2), must—

(a)retain for the required period any documentation that consists of, or reasonably could consist of, any of the documentation referred to in Annex XV, and

(b)comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.

(2) In this regulation, the required period is—

(a)in the case of documentation relating to the clinical investigation of a device that was subsequently placed on the market—

(i)if the device was an implantable device, 15 years after the last device was placed on the market, and

(ii)if the device was not an implantable device, 10 years after the last device was placed on the market;

(b)in any other case, 10 years after the clinical investigation ended.

Clinical investigation fees_I16

16.—(1) The sponsor of a clinical investigation must pay the relevant fee for—

(a)an application submitted to the Secretary of State under Article 70(1);

(b)a notification to the Secretary of State of a substantial modification under Article 75(1).

(2) The relevant fee is payable when the application or notification to which it relates is made to the Secretary of State.

(3) If a sponsor fails to pay the relevant fee, the Secretary of State may reject the application, reject the notification or suspend the clinical investigation until the fee is paid.

(4) Fees for clinical investigations are set out in Schedule 1.

[^F17 (4A) Where the relevant fee is payable pursuant to paragraph (1)(a) 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 application to which it relates is submitted to the Secretary of State and 50% of that fee shall be payable within six months of the date on which the application was submitted.

(4B) For the purpose of this regulation, a company is a small company if, for the financial year before that in which the application or notification is submitted or 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 application or notice is submitted or given (determined on a weekly basis) does not exceed the number specified in item 3 in section 382(3) of that Act.

(4C) 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.^F17]

(5) In this regulation, “the relevant fee” means—

(a)for a clinical investigation of a class I device, class IIa device or [^F18class IIb device, which is neither an implantable device nor a long-term invasive device^F18] , the fee in table 1 in Schedule 1, and

(b)for a clinical investigation of [^F19a class IIb device, which is either an implantable device or a long-term invasive device or a class III device^F19] , the fee in table 2 in Schedule 1.

Clinical investigations not carried out for a purpose specified in Article 62(1)_I17

17.—(1) The provisions in paragraph (2) apply to clinical investigations of custom-made devices carried out for a purpose other than one of the purposes specified in Article 62(1), in addition to the provisions specified in Article 82(1).

(2) The provisions are—

(a)those of Article 62(4) not already specified in Article 82(1);

(b)Article 62(5) and (7);

(c)Article 63 except—

(i) in paragraph (2)(e), not the words “include the Union-wide unique single identification number of the clinical investigation referred to in Article 70(1) and”; and

(ii) in paragraph (6), not the words “in the electronic system on clinical investigations referred to in Article 73”;

(d)Articles 64 to 69;

(e)Article 70 except—

(i)in paragraph (1), not the first sentence of the second subparagraph;

(ii) in paragraph (2), not the final sentence of the paragraph, and in the first sentence the words “data in the electronic system referred to in Article 73” to the end are to be read “documentation and submit the updated documentation to the Secretary of State”;

(iii) in paragraph (3), in the first subparagraph, not the words “by means of the electronic system referred to in Article 73”; and

(iv)paragraphs (8) and (9);

(f)Article 71;

(g)Article 72;

(h) Article 75 except in paragraph (1), not the words “by means of the electronic system referred to in Article 73”;

(i)Article 76 except—

(i) in paragraph (3), not the words “by means of the electronic system referred to in Article 73”; and

(ii) in paragraph (4), not the words “through the electronic system referred to in Article 73”;

(j)Article 77 except—

(i) in paragraphs (1) and (7), not the words “through the electronic system referred to in Article 73”;

(ii)paragraph (4);

(iii)in paragraph (5), not the second sentence of the second subparagraph;

(iv)paragraph (6); and

(v) in paragraph (7), in the second subparagraph, the words “entered into the electronic system pursuant to paragraph (5) of this Article” are to be read “submitted pursuant to paragraph (5) of this Article”;

(k)Article 80 except—

(i) in paragraphs (2) and (3), not the words “by means of the electronic system referred to in Article 73”; and

(ii)paragraphs (4) and (5);

(l)Annex XV except section 3.1.1 in Chapter II.

[^F20Advice in relation to intended clinical investigations

17A.—(1) A manufacturer or sponsor may request a meeting with the Secretary of State in advance of an application being submitted under Article 70(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.

(2) A person who requests a meeting with the Secretary of State under paragraph (1), must pay the following fees in advance of that meeting—

(a)[^F21 £987^F21] for a regulatory advice meeting under paragraph (1)(a); and

(b)[^F22 £852^F22] for a statistical review meeting under paragraph (1)(b).

(3) In this regulation, “ statistical review ” means a review of the statistical sections of the application which a sponsor intends to submit to the Secretary of State under Article 70(1) in respect of an intended clinical investigation. ^F20]

[^F23Part 3A Performance studies under Regulation (EU) 2017/746

Legal representatives and contact persons for performance studies

17B.—(1) The first subparagraph of Article 58(4) (requirement to have a legal representative established in the Union) does not apply to a performance study conducted in Northern Ireland if all of the following conditions are met—

(a)the performance study is also being conducted in Great Britain;

(b)the performance study is not also being conducted in a Member State;

(c)the sponsor—

(i)is established in Great Britain, or

(ii)has a written agreement with a legal representative established in Great Britain who is responsible for ensuring compliance with the sponsor’s obligations under Regulation (EU) 2017/746;

(d)the sponsor has a contact person established in Northern Ireland in respect of the performance study.

(2) A contact person referred to in this regulation must be the addressee for all communications with the sponsor provided for in Regulation (EU) 2017/746 and any communication with that contact person is deemed to be a communication with the sponsor.

(3) The agreement referred to in paragraph (1)(c)(ii) must provide for—

(a)the legal representative to be responsible for ensuring compliance with the sponsor’s obligations under Regulation (EU) 2017/746,

(b)the legal representative to immediately inform the sponsor of all communications received in its capacity as the sponsor’s legal representative, and

(c)the sponsor to share with its legal representative all communications and documentation necessary to enable the legal representative to fulfil its obligations under this regulation.

(4) A legal representative referred to in paragraph (1)(c)(ii) must have a written agreement with the contact person to provide for—

(a)the contact person to immediately inform the legal representative of all communications received in its capacity as the sponsor’s contact person, and

(b)the legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

(5) Where the sponsor is established in Great Britain, the sponsor must have a written agreement with the contact person to provide for—

(a)the contact person to immediately inform the sponsor of all communications received in its capacity as the sponsor’s contact person, and

(b)the sponsor to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

(6) Where the sponsor has a legal representative established in Great Britain, the application form drawn up in accordance with Chapter I of Annex XIV and any clinical performance study plan drawn up in accordance with Part A of Annex XIII must include the name, address and contact details of the legal representative established in Great Britain.

Ethical review of performance studies

17C.—(1) In Regulation (EU) 2017/746 a reference to an ethics committee is a reference to an ethics committee within the meaning of regulation 3(1).

(2) In relation to a performance study to which Article 58(5)(b) applies, the sponsor must submit to the Secretary of State a copy of the opinion of the ethics committee as soon as it becomes available and before the performance study starts.

Arbitration following the refusal of a performance study application

17D.—(1) A sponsor notified of a refusal under Articles 66(3), 67(4) or 74(10) may, within 28 days of being notified, apply to the Institute to appoint an adjudicator to review the refusal.

(2) The adjudicator must provide a report to the Secretary of State and the sponsor, setting out any recommendations in respect of the disputed refusal.

(3) The Secretary of State must take the report of the adjudicator into account and decide whether to—

(a)confirm or alter the grounds for the refusal of the application,

(b)authorise the performance study, or

(c)in the case of a refusal under Article 66(3), proceed to consider the application under Article 66.

(4) The Secretary of State must notify the sponsor of the decision in paragraph (3).

(5) The sponsor must pay any fees, costs and expenses of the Institute and its appointed adjudicator that are payable in connection with the application made under paragraph (1).

Damage compensation in relation to performance studies

17E. A sponsor of a performance study must hold sufficient insurance (or equivalent financial resources) to meet any potential financial liability in the event of injury or death attributable to participation in the performance study.

Retention of documentation relating to performance studies

17F.—(1) The liquidator or trustee in bankruptcy of a sponsor of a performance study, or of a sponsor’s legal representative or contact person under Article 58(4), must—

(a)retain for the required period any documentation that consists of, or reasonably could consist of, any of the documentation referred to in Annex XIV, and

(b)comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.

(2) In this regulation, the required period is—

(a)in the case of documentation relating to the performance study of a device that was subsequently placed on the market, 10 years after the last device was placed on the market;

(b)in any other case, 10 years after the performance study ended.^F23]

PART 4 Notified bodies designated under Regulation (EU) 2017/745 [^F24and Regulation (EU) 2017/746^F24]

Notified bodies_I18

18.—(1) The Secretary of State is the appointed authority responsible for notified bodies under Article 35 [^F25of Regulation (EU) 2017/745 and Article 31 of . Regulation (EU) 2017/746^F25]

(2) In the event of restriction, suspension, or withdrawal of a designation, the notified body must provide the Secretary of State with any documents requested for the purposes of enabling the Secretary of State to exercise the functions of the authority responsible for notified bodies under Article 46(6) [^F26of Regulation (EU) 2017/745 and Article 42(6) of . Regulation (EU) 2017/746^F26]

Fees payable in connection with the designation of notified bodies_I19

19.—(1) Fees in connection with the designation of notified bodies are set out in Schedule 2.

(2) The applicant must pay the Secretary of State the fee specified in table 1 in Schedule 2 for an application—

(a)for initial designation as a notified body under Article 38 [^F27of Regulation (EU) 2017/745 or Article 34 of ;Regulation (EU) 2017/746^F27]

(b)for reassessment under Article 44(10) [^F28of Regulation (EU) 2017/745 or Article 40(10) of ;Regulation (EU) 2017/746^F28]

(c)to extend the scope of a designation under Article 46(1) [^F29of Regulation (EU) 2017/745 or Article 42(1) of .Regulation (EU) 2017/746^F29]

(3) A notified body designated by the Secretary of State under Article 42 [^F30of that submits a summary evaluation report to the Secretary of State in accordance with Regulation (EU) 2017/745^F30] Article 5(4) of Regulation (EU) 722/2012, must pay to the Secretary of State a fee of [^F31£1,503^F31] .

(4) A fee specified in table 1 in Schedule 2 or paragraph (3) is payable when the application or submission to which it relates is made to the Secretary of State.

(5) If an applicant fails to pay a fee specified in table 1 in Schedule 2 or paragraph (3), the Secretary of State may reject the application or submission to which it relates.

(6) If the Secretary of State conducts an assessment or review listed in table 2 in Schedule 2, the fee payable by the conformity assessment body is—

(a)the fee specified for that assessment or review in table 2 in Schedule 2,

(b)an amount for time spent by each member of staff to undertake the assessment or review at a rate—

(i)for the time spent on site, of [^F32£732^F32] per half day (period of less than a half day counting as a half day) up to a maximum of 2 half days on any one date, and

(ii)for the time spent travelling to and from the site, of [^F33£198^F33] per hour,

(c)the actual costs of travel, accommodation and subsistence, and

(d)out of pocket expenses.

(7) A fee under paragraph (6) is payable within one month of receipt by the conformity assessment body of a written notice from the Secretary of State requiring payment of the fee.

(8) If a conformity assessment body fails to pay a fee under paragraph (6), the Secretary of State may—

(a)refuse to designate the body under Article 42 [^F34of Regulation (EU) 2017/745 or Article 38 of ;Regulation (EU) 2017/746^F34]

(b)if the body has already been designated, suspend, restrict, or fully or partially withdraw, the designation.

(9) In this regulation, “ Regulation (EU) 722/2012 ” means of 8th August 2012 concerning particular requirements as regards the requirements laid down in Council Directives Commission Regulation (EU) No 722/2012 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin( 5 ).

[^F35Part 4A Fees for consultation in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device

Interpretation of Part 4A

19A. In this Part—

“ approved manufacturer ” in relation to a medicinal substance means a manufacturer who—

“ authorised medicinal product ” means a medicinal product in respect of which a marketing authorisation has been granted;

“ clinical development ” means the conduct of studies of a medicinal substance in human subjects in order to—

with the object of ascertaining the safety or efficacy of that substance, as required to verify the safety and usefulness of the substance in accordance with section 12.1 of Annex I;

“ consultation ” means a consultation required by section 5.2 or 5.4 of Annex IX or section 6 of Annex X;

“ further consultation ” means a consultation by a notified body in relation to any device which—

“ incorporates ” means incorporates as an integral part;

“ marketing authorisation ” has the meaning given by regulation 8 of the Human Medicines Regulations 2012 ;

“ medicinal substance ” means a substance which, if used separately from a device, may be considered to be a medicinal product, as defined in Schedule 1 (General interpretation provisions) to the Medicines (Products for Human Use) Fees Regulations 2016 ;

“ new medicinal substance ” means a medicinal substance which is not—

“ quality development ” means the chemical, pharmaceutical and biological testing required in order to verify the quality of a medicinal substance in accordance with section 12.1 of Annex I;

“ relevant conformity assessment certificate ” means either an EU technical documentation assessment certificate issued in accordance with Annex IX or an EU type-examination certificate issued in accordance with Annex X;

“ relevant period ” means the period of 5 years which starts on the first day on which the Secretary of State was consulted in respect of the unsuccessful application or, if there has been more than one such application in any particular case, in respect of the first of them;

“ safety development ” means the toxicological and pharmacological testing required in order to verify the safety of a medicinal substance in accordance with section 12.1 of Annex I; and

“ scientific advice ” means advice in connection with the quality, safety or clinical development for a medicinal substance incorporated, or to be incorporated, in a device.

Circumstances 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

19B.—(1) Subject to paragraph (2), the fee payable by a notified 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 regulations 19C.

(2) No fee is payable if it is the first time the Secretary of State has been consulted by any notified 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.

Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device

19C.—(1) Subject to regulation 19B(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)[^F36 £4,953^F36] if each medicinal substance is manufactured by an approved manufacturer of that substance;

(b)[^F37 £11,543^F37] 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)[^F38 £980^F38] if each medicinal substance is manufactured by an approved manufacturer of that substance;

(b)[^F39 £2,668^F39] 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)[^F40 £50,644^F40] for a consultation; and

(b)[^F41 £12,574^F41] for a further consultation.

(4) Where a notified 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 the notified body consults the Secretary of State.^F35]

Fees for pre-consultation meetings

^F4219D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 5 General provision about language requirements and fees

Language requirements_I20

20. Where Regulation (EU) 2017/745[^F43 or Regulation (EU) 2017/746 provide^F43] for the UK in respect of Northern Ireland to determine the language requirements for information and documentation, such information and documentation must be written in English.

Unpaid fees_I21

21. All unpaid sums due by way of, or on account of, any fees payable under these Regulations are recoverable as debts due to the Crown.

Waivers, reductions and refunds_I22

22. The Secretary of State may—

(a)waive payment of any fee or reduce any fee or part of a fee otherwise payable under these Regulations;

(b)refund the whole or part of any fee paid pursuant to these Regulations.

PART 6 Enforcement

Offence of breaching certain provisions_I23

23.[^F44—(1) A person commits an offence if the person contravenes a prohibition or fails to comply with a requirement in a provision of—

(a)the regulations listed in Table 1;

(b)the articles of Regulation (EU) 2017/745 listed in Table 2;

(c)the articles of Regulation (EU) 2017/746 listed in Table 3;

in Schedule 3 to these Regulations.^F44]

(2) A person guilty of an offence under paragraph (1) is liable on summary conviction to imprisonment for a term not exceeding 6 months, to a fine not exceeding level 5 on the standard scale or to both.

(3) In respect of an offence under this regulation, a magistrates’ court in Northern Ireland may hear and determine any complaint made before the earlier of—

(a)the end of the period of 1 year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and

(b)the end of the period of 3 years beginning with the day on which the offence was committed.

(4) For the purposes of paragraph (3)(a)—

(a)a certificate signed by or on behalf of the prosecutor and stating the date on which such evidence came to the prosecutor’s knowledge is conclusive evidence of that fact, and

(b)a certificate stating that matter and purporting to be so signed is to be treated as so signed until the contrary is proved.

Defence of due diligence_I24

24.—(1) It is a defence for a person charged with an offence under regulation 23(1) to show that the person took all reasonable steps and exercised all due diligence to avoid commission of the offence.

(2) If in any proceedings for such an offence the defence provided by paragraph (1) involves an allegation that the commission of the offence was due to—

(a)an act or default of another person, or

(b)reliance on information given by another person,

the defendant is not, without leave of the court, entitled to rely on that defence unless the requirement in paragraph (3) is satisfied.

(3) The requirement is that at least 7 clear days before the hearing of the proceedings the defendant has served on the prosecutor a notice giving such information identifying or assisting in the identification of that other person as was then in the defendant’s possession.

(4) A defendant is not entitled to rely on the defence provided by paragraph (1) by reason of the defendant’s reliance on information supplied by another person unless the defendant shows that it was reasonable in all the circumstances to rely on the information, having regard in particular to—

(a)the steps which the defendant took or might reasonably have taken to verify the information, and

(b)whether the defendant had any reason to disbelieve the information.

Offences by bodies corporate_I25

25.—(1) Where an offence under regulation 23(1) committed by a body corporate or a Scottish partnership is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, an officer, the officer (as well as the body corporate or partnership) commits the offence and is liable to be proceeded against and punished accordingly.

(2) In relation to a body corporate, “officer” means—

(a)a director, manager, secretary or other similar officer of the body, or

(b)a person purporting to act in any such capacity.

(3) In paragraph (2)(a), “director”, in relation to a body corporate whose affairs are managed by its members, means a member of the body corporate.

(4) In relation to a Scottish partnership, “officer” means—

(a)a partner, or

(b)a person purporting to act as a partner.

Enforcement_I26

26.—(1) It is the duty of the Secretary of State to enforce these Regulations [^F45, Regulation (EU) 2017/745 and . Regulation (EU) 2017/746^F45]

(2) It is the duty of each district council in Northern Ireland to enforce these Regulations [^F46, Regulation (EU) 2017/745 and within its area (concurrently with the Secretary of State) in relation to devices that are ordinarily intended for private use or consumption. Regulation (EU) 2017/746^F46]

PART 7 Amendment of primary legislation

Investigatory powers under the Consumer Rights Act 2015_I27

27.—(1) Schedule 5 to the Consumer Rights Act 2015(6)(investigatory powers etc) is amended in accordance with this regulation.

(2) In paragraph 8 (interpretation of Schedule 5), after the definition of “online interface order” insert—

““Regulation (EU) 2017/745 on medical devices” 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.”

(3) In paragraph 10 (enforcer’s legislation: duties and powers mentioned in paragraph 9(1)(a)) at the end insert “regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021”.

(4) In paragraph 19 (exercise of powers in Part 4), in sub-paragraph (7A)(a)(7), for the words from “a breach of” to the end substitute—

“a breach of—

(i)the Medical Devices Regulations 2002 (S.I. 2002/618),

(ii)regulations made under section 15(1) of the Medicines and Medical Devices Act 2021,

(iii)the Medical Devices (Northern Ireland Protocol) Regulations 2021, or

(iv)Regulation (EU) 2017/745 on medical devices, and”.

(5) In paragraph 30A(8) (power to decommission or switch off fixed medical devices)—

(a)in sub-paragraph (1), for the words from “pursuant to” to the end substitute—

“pursuant to—

(a)the duty in regulation 61(1A) or (1B) of the Medical Devices Regulations 2002 (S.I. 2002/618),

(b)a duty in regulations made under section 15(1) of the Medicines and Medical Devices Act 2021, or

(c)the duty in regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021.”;

(b)in sub-paragraph (2), for “medical device to which the Medical Devices Regulations 2002 apply” substitute “relevant medical device”;

(c)after sub-paragraph (2), insert—

“(3) In sub-paragraph (2), “relevant medical device” means—

(a)where a domestic enforcer is acting pursuant to a duty mentioned in sub-paragraph (1)(a) or (b), any medical device to which the Medical Devices Regulations 2002 apply;

(b)where a domestic enforcer is acting pursuant to the duty mentioned in sub-paragraph (1)(c), any medical device to which Regulation (EU) 2017/745 on medical devices applies.”

Amendment of the Medicines and Medical Devices Act 2021_I28

28.—(1) The Medicines and Medical Devices Act 2021(9) is amended in accordance with this regulation.

(2) In section 17 (fees, information, offences), in subsection (2), for “this Part” substitute “this Chapter”.

(3) In section 21 (compliance notices), after subsection (1), insert—

“(1A) In this Chapter, “medical devices provision” means a provision in—

(a)regulations under section 15(1),

(b)the Medical Devices Regulations 2002 (S.I. 2002/618),

(c)the Medical Devices (Northern Ireland Protocol) Regulations 2021, or

(d)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.”

(4) In section 34 (recovery of expenses of enforcement), in subsection (1)(a), for the words from “offence under” to the end substitute—

“offence under—

(i)section 28,

(ii)regulation 60A of the Medical Devices Regulations 2002 (S.I. 2002/618) (offence of breaching certain provisions in the Regulations), or

(iii)regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021 (offence of breaching certain provisions),

in relation to a medical device, or”.

(5) In section 39 (disclosure of information)—

(a)in subsection (10)(a), omit the “or” at the end;

(b)in subsection (10)(b), at the end insert—

“, or

(c)contravenes any obligation or restriction created or arising by or under the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement, whether or not an obligation or restriction to which section 7A(2) of the European Union (Withdrawal) Act 2018 applies.”.

(6) In section 42 (interpretation of Part 4), in subsection (2)—

(a)for the definition of “manufacturer” substitute—

““manufacturer” means any person who is a manufacturer for the purposes of any provision in—

(b)for the definition of “medical devices provision” substitute—

““medical devices provision”—

(7) In Schedule 2 (medical devices: civil sanctions)—

(a)in paragraph 1(1) (imposition of monetary penalty)—

(i)in paragraph (a), omit the “or” at the end;

(ii)in paragraph (b), at the end insert—

“, or

(c)regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021 (offence of breaching certain provisions).”;

(b)in paragraph 4 (monetary penalties: criminal proceedings and conviction)—

(i)in sub-paragraph (1)(a), from “offence under” to the end substitute—

“offence under—

(i)section 28,

(ii)regulation 60A of the Medical Devices Regulations 2002, or

(iii)regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021,

may be instituted against the person in respect of the act or omission to which the notice relates before the end of the period within which the person’s liability may be discharged as mentioned in paragraph 2(2) (see paragraph 3(2)(a));”;

(ii)in sub-paragraph (1)(b), from “section 28” to the end substitute “the provisions mentioned in paragraph (a) in relation to that act or omission.”;

(iii)in sub-paragraph (2), from “section 28” to the end substitute “any of the provisions mentioned in sub-paragraph (1)(a) in respect of the act or omission giving rise to the penalty.”;

(c)paragraph 5 (enforcement undertakings)—

(i)in sub-paragraph (1)(a), from “offence under” to the end substitute—

“offence under—

(i)section 28,

(ii)regulation 60A of the Medical Devices Regulations 2002, or

(iii)regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021,”;

(ii)in sub-paragraph (2)(a), from “section 28” to the end substitute “any of the provisions mentioned in sub-paragraph (1)(a) in respect of the act or omission to which the undertaking relates;”;

(d)in paragraph 13 (guidance as to enforcement), in sub-paragraph (1)(a), for “or regulation 60A” to the end substitute “, regulation 60A of the Medical Devices Regulations 2002 or regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021;”.

PART 8 Amendment of the Medical Devices Regulations 2002

Amendments to the Medical Devices Regulations 2002_I29

29. The Medical Devices Regulations 2002(10) are amended in accordance with this Part.

Amendment of regulation 2 (interpretation)_I30

30. In regulation 2, in paragraph (1)—

(a)for the definition of “medical device” substitute—

““medical device” has the meaning given in Article 2(1) of Regulation (EU) 2017/745 and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;”;

(b)after the definition of “Regulation 722/2012” insert—

““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;”.

Amendment of regulation 2A (medical devices which are qualifying Northern Ireland goods) _I31

31. In regulation 2A—

(a)in paragraph (1)(a), after “Northern Ireland” insert “or of Regulation (EU) 2017/745”;

(b)in paragraph (2)—

(i)the words from ““qualifying Northern Ireland good”” to the end become sub-paragraph (a); and

(ii)after that sub-paragraph insert—

“(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.”.

Revocation and transitional provision_I32

32. After regulation 3 (scope), insert—

Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745

3ZA.—(1) Subject to paragraph (2)—

(a)Parts 2 and 3 only apply in Northern Ireland for the purposes of regulating qualifying devices.

(b)Parts 5 to 7 only apply in Northern Ireland for the purposes of regulating qualifying devices and devices within the scope of Part 4.

(2) The following provisions continue to apply in Northern Ireland in accordance with this paragraph whether or not the device to which they apply is referred to in paragraph (1)—

(a)for the purposes of registration of medical 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), and

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

apply until the date which is 6 months after the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745.

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

(3) For the purposes of paragraph (1), a device is a qualifying device if, by virtue of Article 120 of Regulation (EU) 2017/745—

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

(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, 3 and 5 to 7.”

Amendment of regulation 10A (UK(NI) indication: general medical devices)_I33

33. In regulation 10A, after paragraph (3), insert—

“(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.”

Amendment of regulation 19 (registration of persons placing general medical devices on the market) _I34

34. In regulation 19—

(a)omit paragraph (1)(a)(ii);

(b)in paragraph (1)(b) for “and custom-made devices” substitute “that are not custom-made devices”;

(c)omit paragraph (2)(c);

(d)omit paragraph (5); and

(e)omit paragraph (6).

Amendment of regulation 21B (registration of persons placing active implantable medical devices on the market) _I35

35. In regulation 21B—

(a)omit paragraph (1)(a)(ii);

(b)omit paragraph (1)(b);

(c)omit paragraph (2)(c);

(d)omit paragraph (5); and

(e)omit paragraph (6).

Amendment of regulation 24A (UK(NI) indication: active implantable medical devices)_I36

36. In regulation 24A, after paragraph (3), insert—

“(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.”

Amendment of regulation 36A (UK(NI) indication: in vitro diagnostic medical devices)_I37

37. In regulation 36A, after paragraph (3), insert—

“(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.”

PART 9 Amendments of other secondary legislation

Amendment of the Blood Safety and Quality Regulations 2005_I38

38. In the Blood Safety and Quality Regulations 2005(11), in regulation 2 (scope of the regulations), in paragraph (3), at the end insert “and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending , Regulation Directive 2001/83/EC(EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC”.

Amendment of the Human Tissue (Quality and Safety for Human Application) Regulations 2007_I39

39. In the Human Tissue (Quality and Safety for Human Application) Regulations 2007(12), in regulation 2 (extent and application)—

(a)in paragraph (3)(c), omit the “or” at the end; and

(b)in paragraph (3)(d), at the end insert—

“, or

(e)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.”

Amendment of the Legislative and Regulatory Reform (Regulatory Functions) Order 2007_I40

40.—(1) The Legislative and Regulatory Reform (Regulatory Functions) Order 2007(13) is amended as follows.

(2) In Part 2 of the Schedule, in the section headed “Medicines”, after “Human Medicines Regulations 2012”, insert—

• “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

• Medical Devices (Northern Ireland Protocol) Regulations 2021”.

(3) In Part 3 of the Schedule, in the section headed “Public health and safety”, after “The Personal Protective Equipment (Enforcement) Regulations 2018”, insert “The Medical Devices (Northern Ireland Protocol) Regulations 2021”.

Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016_I41

41. In the Medicines (Products for Human Use) (Fees) Regulations 2016(14), in regulation 10(5) (fee for advice for other purposes)—

(a)in paragraph (a), omit the “or” at the end; and

(b)in paragraph (b), at the end insert—

“; or

(c)obtaining an EU technical documentation assessment certificate or EU type-examination certificate of the type mentioned in section 5 of Annex IX and section 6 of Annex X of 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, for a medical device incorporating that product or a product of that type.”

Amendment of the Economic Growth (Regulatory Functions) Order 2017_I42

42. In the Economic Growth (Regulatory Functions) Order 2017(15), in Part 3 of the Schedule, in the section headed “Medicines”, after “Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, , Directive 2001/20/EC and Regulation Directive 2001/83/EC(EC) No 726/2004”, insert—

• “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

• Medical Devices (Northern Ireland Protocol) Regulations 2021”.

Amendment of the Market Surveillance (Northern Ireland) Regulations 2021_I43

43.—(1) The Market Surveillance (Northern Ireland) Regulations 2021(16) are amended as follows.

(2) In regulation 6 (enforcer’s legislation), at the end insert—

“(rr)regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021.”

(3) In Schedule 1 (investigatory powers)—

(a)in paragraph 1 (interpretation of terms used in this schedule), at the end insert—

““Regulation (EU) 2017/745 on medical devices” 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.”

(b)in paragraph 16 (power to decommission or switch off any medical device)—

(i)in sub-paragraph (1), for the words from “pursuant to” to the end substitute—

“pursuant to—

(a)the duty in regulation 61(1A) or (1B) of the Medical Devices Regulations 2002,

(b)a duty in regulations made under section 15(1) of the Medicines and Medical Devices Act 2021, or

(c)the duty in regulation 26(1) or (2) of the Medical Devices (Northern Ireland Protocol) Regulations 2021.”;

(ii)in sub-paragraph (2), after “Medical Devices Regulations 2002” insert “or Regulation (EU) 2017/745 on medical devices”;

(iii)in sub-paragraph (3)(a)(ii), after “Medicines and Medical Devices Act 2021;”, omit “and”;

(iv)after sub-paragraph (3)(a)(ii) insert—

“(iii)the Medical Devices (Northern Ireland Protocol) Regulations 2021;

(iv)Regulation (EU) 2017/745 on medical devices; and”.

Regulation 16

SCHEDULE 1 Fees for clinical investigations _I44

Regulation 19

SCHEDULE 2 Fees in connection with the designation of notified bodies _I45

Regulation 23

SCHEDULE 3 Provisions breach of which is an offence under regulation 23 _I46