The Medical Devices (Amendment) Regulations 2013

• Citation: S.I. 2013/2327
• Sections: 22

Section 1 Citation, commencement and interpretation

(1) These Regulations may be cited as the Medical Devices (Amendment) Regulations 2013.

(2) These Regulations shall come into force on 21st October 2013.

(3) In these Regulations “the 2002 Regulations ” means the Medical Devices Regulations 2002 .

Section 2 Amendment of regulation 2 of the 2002 Regulations

(1) Regulation 2 of the 2002 Regulations (interpretation) is amended as follows.

(2) In paragraph (1) omit the following definitions—

(a) “animal”;

(b) “Directive 2003/32”;

(c) “ EEA State”;

(d) “non-viable”; and

(e) “tissue”.

(3) In paragraph (1) for the definition of “European Economic Area” substitute—

“European Economic Area” means the European Economic Area created by the EEA Agreement;

(4) In paragraph (1) in the definition of “the Medical Devices Directives” for “read with Directive 2003/32” substitute “both read with Regulation ( EU ) No 207/2012 and Regulation (EU) No 722/2012”.

(5) In paragraph (1) after the definition of “putting into service” insert the following definitions—

“Regulation (EU) No 207/2012” means Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices ;

“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 ;

(6) After paragraph (1A) insert the following paragraph—

(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.

Section 3 Amendment of regulation 8 of the 2002 Regulations

In regulation 8(1) and (2) of the 2002 Regulations (essential requirements for general medical devices) after “apply to it” insert “and the requirements set out in Regulation (EU) No 722/2012 (if applicable)”.

Section 4 Amendment of regulation 13 of the 2002 Regulations

(1) Regulation 13 of the 2002 Regulations (procedures for affixing a CE marking to general medical devices) is amended as follows.

(2) In paragraph (4)—

(a) in sub-paragraph (b) omit “and”;

(b) at the end of sub-paragraph (c) add “and”; and

(c) after sub-paragraph (c) add the following sub-paragraph—

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

(3) Omit paragraphs (5) and (6).

Section 5 Amendment of regulation 15 of the 2002 Regulations

In regulation 15(a) of the 2002 Regulations (procedures for custom-made general medical devices) after “Annex VIII ” insert “, read with Regulation (EU) No 722/2012”.

Section 6 Amendment of regulation 16 of the 2002 Regulations

In regulation 16(1)(a) of the 2002 Regulations (procedures for general medical devices for clinical investigations) after “Annex VIII” insert “, read with Regulation (EU) No 722/2012”.

Section 7 Amendment of regulation 17 of the 2002 Regulations

Omit regulation 17(4) and (5) of the 2002 Regulations (manufacturers etc. and conformity assessment procedures for general medical devices).

Section 8 Amendment of regulation 18 of the 2002 Regulations

In regulation 18(1)(b) of the 2002 Regulations ( UK notified bodies and the conformity assessment procedures for general medical devices) for “EEA State” substitute “EEA State”.

Section 9 Omission of regulation 19A of the 2002 Regulations

Omit regulation 19A of the 2002 Regulations (additional requirements relating to use of animal tissue).

Section 10 Amendment of regulation 22 of the 2002 Regulations

In regulation 22(1) and (2) of the 2002 Regulations (essential requirements for active implantable medical devices) after “apply to it” insert “and the requirements set out in Regulation (EU) No 722/2012 (if applicable)”.

Section 11 Amendment of regulation 27 of the 2002 Regulations

In regulation 27 of the 2002 Regulations (procedures for affixing a CE marking to active implantable medical devices)—

(a) in paragraph (b) omit “and”;

(b) at the end of paragraph (c) add “and”; and

(c) after paragraph (c) add the following paragraph—

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

Section 12 Amendment of regulation 28 of the 2002 Regulations

In regulation 28(a) of the 2002 Regulations (procedures for custom-made active implantable medical devices) after “Annex 6” insert “, read with Regulation (EU) No 722/2012”.

Section 13 Amendment of regulation 29 of the 2002 Regulations

In regulation 29(1)(a) of the 2002 Regulations (procedures for general medical devices for clinical investigations) after “Annex 6” insert “, read with Regulation (EU) No 722/2012”.

Section 14 Amendment of regulation 45 of the 2002 Regulations

(1) Regulation 45 of the 2002 Regulations (designation etc. of UK notified bodies) is amended as follows.

(2) In paragraph (2)(a) after “Annex 8 of that Directive” insert “, read with Regulation (EU) No 722/2012,”.

(3) In paragraph (2)(b) for “article 4 of Directive 2003/32” substitute “Regulation (EU) No 722/2012”.

(4) In paragraphs (5)(b), (7) and (8) for “read with article 4 of Directive 2003/32” substitute “both read with Regulation (EU) No 722/2012”.

Section 15 Amendment of regulation 47 of the 2002 Regulations

Omit regulation 47(9) and (10) of the 2002 Regulations (general matters relating to UK notified bodies).

Section 16 Amendment of regulation 54 of the 2002 Regulations

In regulation 54(3) of the 2002 Regulations (fees payable in connection with the designation etc. of UK notified bodies) for “read with article 4 of Directive 2003/32” substitute “both read with Regulation (EU) No 722/2012”.

Section 17 Amendment of regulation 61 of the 2002 Regulations

In regulation 61(8)(a)(i) of the 2002 Regulations (enforcement etc.) after “requirement” insert “or a requirement of Regulation (EU) No 722/2012 (if applicable)”.

Section 18 Insertion of regulation 67 into the 2002 Regulations

After regulation 66 of the 2002 Regulations (revocations) insert the following regulation—

Review

(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.

Section 19 Amendment of Schedule 1 to the 2002 Regulations

For paragraph 1 of Schedule 1 to the 2002 Regulations (association agreements) substitute—

(1) The Agreement establishing an Association between the European Economic Community and Turkey signed at Ankara on 12th September 1963.

Section 20 Amendment of Schedule 2 to the 2002 Regulations

In Schedule 2 to the 2002 Regulations (mutual recognition agreements) after paragraph 4 add the following paragraph—

(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.

Section 21 Part-revocation of the Medical Devices (Amendment) Regulations 2003

The following provisions of the Medical Devices (Amendment) Regulations 2003 are revoked—

(a) regulation 2(b), (c) insofar as it inserts a definition of “Directive 2003/32”, (e) and (g);

(b) regulation 6;

(c) regulation 7;

(d) regulation 9;

(e) regulation 13;

(f) regulation 14; and

(g) regulation 16.

Section 22 Part-revocation of the Medical Devices (Amendment) Regulations 2012

Regulation 3 of the Medical Devices (Amendment) Regulations 2012 (review) is revoked.