Citation, commencement and interpretation

1. —(1) These Regulations may be cited as the Medical Devices (Amendment) Regulations 2008 and shall come into force on 21st March 2010.

(2) In these Regulations, “the principal Regulations” mean the Medical Devices Regulations 2002( 4 ).

Amendment of regulation 2 of the principal Regulations

2. In regulation 2 of the principal Regulations (interpretation), in paragraph (1)—

(a) in the definition of “animal”, after “animal” insert—

“ for the purpose of regulations 13,17, 19A and 47 ” ;

(b) at the end of the definition of “authorised representative” insert—

“ with regard to the latter’s obligation under Directive 90/385, Directive 93/42 and Directive 98/79 ” ;

(c) after the definition of “the Community” insert—

“ “ clinical data ” means the safety or performance information that is generated from the use of a device, derived from—

(d) after the definition of “Directive 2005/50”, insert—

“ “ Directive 2007/47 ” means Directive 2007/47/EC of the European Parliament and of the Council amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market ( 5 ) ;

“ Directive 2006/42/EC ” means Directive 2006/42/EC of the European Parliament and of the Council on machinery ( 6 ) ; ” ;

(e) after the definition of “harmonised standard” insert—

“ “ hazard ” means a potential source of injury or damage to health; ” ;

(f) for the definition of “intended for clinical investigation” substitute—

“ “ intended for clinical investigation ” means—

(g) after the definition of “in vitro diagnostic medical device” insert—

“ “ machinery ” has the meaning given to it by Article 2(a) of Directive 2006/42; ” ;

(h) in the definition of “medical device” for “an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application,” substitute “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application,”; and

(i) omit the definition of “medical specialist”.

Amendment of regulation 3 of the principal Regulations

3. In regulation 3 of the principal Regulations (scope of these Regulations)—

(a) in paragraph (d), omit “active implantable medical devices”;

(b) in paragraph (d), after “such devices” insert “save where medicinal products are incorporated as ancillary to the device”;

(c) in paragraph (e)(ii) omit “an active implantable medical device or”; and

(d) omit paragraph (g).

Amendment of regulation 5 of the principal Regulations

4. In regulation 5 of the principal Regulations (interpretation of Part II), in paragraph (1), in the definition of “custom-made device” for “duly qualified medical practitioner or professional user” substitute “registered medical practitioner, or other person authorised to write such a prescription by virtue of his professional qualification,”.

Amendment of regulation 8 of the principal Regulations

5. In regulation 8 of the principal Regulations (essential requirements for general medical devices), after paragraph (2) add—

“ (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. ” .

Amendment of regulation 9 of the principal Regulations

6. In regulation 9 of the principal Regulations (determining compliance of general medical devices with relevant essential requirements)—

(a) after paragraph (5), insert—

“ (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. ” ; and

(b) after sub-paragraph (8) insert—

“ (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 ( 7 ) and Directive 93/42, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled. ” .

Amendment of regulation 14 of the principal Regulations

7. In regulation 14 of the principal Regulations (procedures for systems and procedure packs, and for devices to be sterilised before use), in paragraph (4)—

(a) for sub-paragraph (a), substitute—

“ (a) follow the procedures referred to in either Annex II or IV that relate to obtaining sterility; and ” ; and

(b) after paragraph (4) insert—

“ (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. ” .

Amendment of regulation 15 of the principal Regulations

8. In regulation 15 of the principal Regulations (procedure for custom-made general medical devices)—

(1) at the end of paragraph (c) omit “and”; and

(2) after paragraph (d) insert—

“ ;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. ” .

Amendment of regulation 16 of the principal Regulations

9. In regulation 16 of the principal Regulations (procedures for general medical devices for clinical investigations) —

(a) in paragraph (1)(a)—

“ for “Sections 1 and 2” substitute “Sections 1 and 2.2 ” ; and

(b) after paragraph (10) add—

“ (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. ” .

Amendment of regulation 18 of the principal Regulations

10. In regulation 18 of the principal Regulations (UK notified bodies and conformity assessment procedures for general medical device), in paragraph (2), for “Annex II or III” substitute “Annex II, III, V or VI,”.

Amendment of regulation 19 of the principal Regulations

11. In regulation 19 of the principal Regulations (registration of persons placing general medical devices on the market)—

(a) in paragraph (3), in sub-paragraph (c), for “the manufacturer’s” substitute “the manufacturer’s single authorised representative”; and

(b) in paragraph (5), for “ Class IIb or III ” (in each place that it occurs), substitute “Class IIa, IIb or III”.

Amendment of regulation 21 of the principal Regulations

12. In regulation 21 of the principal Regulations (scope of Part III)—

(a) the existing paragraph shall be numbered (1); and

(b) after paragraph 1 add—

“ (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 Directive 2001/83/EC . ” .

Amendment of regulation 29 of the principal Regulations

13. In regulation 29 of the principal Regulations (procedures for active implantable medical devices for clinical investigations), after paragraph (9) add—

“ (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. ” .

Amendment of regulation 30 of the principal Regulations

14. In regulation 30 of the principal Regulations (manufacturers and conformity assessment procedures for active implantable medical devices), after paragraph (2), add—

“ (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 a Member State, the manufacturer shall—

(a) designate a single authorised representative; and

(b) ensure that the authorised representative has a registered place of business in a Member State.

(5) The authorised representative referred to in paragraph (4) shall provide the competent authority of the Member State in which they have their registered place of business with the information referred to in paragraph (3) above. ” .

Amendment of regulation 31 of the principal Regulations

15. In regulation 31 of the principal Regulations (UK notified bodies and conformity assessment procedures for active implantable medical devices), in paragraph (2), for “Annex 2 or 3” substitute “Annex 2, 3 or 5”.

Amendment of regulation 47 of the principal Regulations

16. In regulation 47 of the principal Regulations (general matters relating to UK notified bodies), in paragraphs (4) and (5), omit the words “other than active implantable medical devices”.

Amendment of regulation 60 of the principal Regulations

17. In regulation 60 of the principal Regulations (designation etc of authorised representatives)—

(a) in paragraphs (1), (2) and (3) replace the words “an authorised representative”, in each place that they occur, with “a single authorised representative”; and

(b) in paragraph (4) replace “evidence that he is an authorised representative of the manufacturer” with “evidence that he is the single authorised representative of the manufacturer”.

Amendment of regulation 63 of the principal Regulations

18. In regulation 63 of the principal Regulations (restriction notices)—

(a) in paragraph (1) omit “subject to paragraph (2),”; and

(b) omit paragraph (2).