The Medical Devices (Amendment) Regulations 2012

Made: 29th May 2012

Laid before Parliament: 11th June 2012

Coming into force: 1st July 2012

The Secretary of State makes the following Regulations, in exercise of the powers conferred on him by section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972 and section 11 of the Consumer Protection Act 1987 . He is designated for the purpose of section 2(2) of the European Communities Act 1972 in relation to medical devices .

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for references to Annexes 1 to 7 to Directive 90/385/EEC, Annexes I to X to Directive 93/42/EEC, and Annex I to X to Directive 98/79/EC to be construed as a reference to those provisions as are amended from time to time.

In accordance with section 11(5) of the Consumer Protection Act 1987, he has consulted such organisations as appeared to him to be representative of interests substantially affected by these Regulations, such other persons as he considered appropriate and the Health and Safety Executive.

Citation, commencement and interpretation

1

• (1) These Regulations may be cited as the Medical Devices (Amendment) Regulations 2012 and shall come into force on 1st July 2012.

• (2) In these Regulations—

“the 2002 Regulations” means the Medical Devices Regulations 2002

Amendment of the Medical Devices Regulations 2002

2

Regulation 2 (interpretation) of the Medical Devices Regulations 2002 is amended as follows:

• (a) in paragraph (1),

• (i) for the definition of “Directive 90/385”, substitute—

“Directive 90/385” means Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of Member States relating to active implantable devices .

• (ii) For the definition of “Directive 93/42”, substitute—

“Directive 93/42” means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices .

• (iii) For the definition of “Directive 98/79”, substitute—

“Directive 98/79” means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices .

• (b) after paragraph (1), insert—

(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.

Review

3

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Signed

Signed by authority of the Secretary of State for Health.

Earl Howe — Parliamentary Under-Secretary of State, — 2012-05-29

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 1972 c.68; section 2(2) was amended by the Legislative and Regulatory Reform Act 2006 c.51, section 27(1)(a) and the European Union (Amendment) Act 2008 section 3(3) and Schedule Part 1.

[^f00002]: 1987 c.43; section 11 was amended by S.I.2005/1803 and 2008/960; there are other amendments but none are relevant.

[^f00003]: Designation in relation to active implantable medical devices is by S.I.1991/2289 and for other devices is by S.I.1993/2661.

[^f00004]: S.I.2002/618; as amended by S.I.2003/1697, 2007/803 and 2008/2936.

[^f00005]: Directive 90/385/EEC as amended by Council Directive 93/43/EEC (OJ No.L.169, 12/7/1993, p.1), Council Directive 93/68/EEC (OJ No.L.220, 30.8.1993, p.1), Regulation (EC) No.1882/2003 (OJ No. L284, 31.10.2003, p.1) and Directive 2007/47/EC (OJ No. 1.247, 21.9.2007, p.21).

[^f00006]: Directive 93/42/EEC was amended by Directive 98/79/EC (OJ No. L.331, 7.12.1998, p.1), Directive 2000/70/EC (OJ No. L.313, 13.12.2000, p.22), Directive 2001/104/EU (OJ No. L.6, 10.1.2002, p.50) and Directive 2007/47/EC (OJ No. L.247, 21.9.2007, p.21).

[^f00007]: Directive 98/79/EC was amended by Regulation (EC) No 1882/2003 (OJ No. L.284, 31.10.2003, p.1), Regulation (EC) No. 596/2009 (OJ No. L.188, 18.7.2009, p.14) and Directive 2011/100 (OJ No. L.341, 22.12.2011, p.50) and was corrected by Corrigendum (OJ No. L.22, 29.1.1999, p.75) and Corrigendum (OJ No. L.6, 10.1.2002, p.70).

[^f00008]: Directive 2007/47/EC of the European Parliament and of the Council (OL No.L.247, 21.9.2007, p.21-55).

[^f00009]: Commission Directive 2011/100/EU (OJ No.L.341, 22.12.2011, p.50).

Editorial notes

[^c21293741]: 1972 c.68; section 2(2) was amended by the Legislative and Regulatory Reform Act 2006 c.51, section 27(1)(a) and the European Union (Amendment) Act 2008 section 3(3) and Schedule Part 1.

[^c21293751]: 1987 c.43; section 11 was amended by S.I.2005/1803 and 2008/960; there are other amendments but none are relevant.

[^c21293761]: Designation in relation to active implantable medical devices is by S.I.1991/2289 and for other devices is by S.I.1993/2661.

[^c21293771]: S.I.2002/618; as amended by S.I.2003/1697, 2007/803 and 2008/2936.

[^c21293781]: Directive 90/385/EEC as amended by Council Directive 93/43/EEC (OJ No.L.169, 12/7/1993, p.1), Council Directive 93/68/EEC (OJ No.L.220, 30.8.1993, p.1), Regulation (EC) No.1882/2003 (OJ No. L284, 31.10.2003, p.1) and Directive 2007/47/EC (OJ No. 1.247, 21.9.2007, p.21).

[^c21293791]: Directive 93/42/EEC was amended by Directive 98/79/EC (OJ No. L.331, 7.12.1998, p.1), Directive 2000/70/EC (OJ No. L.313, 13.12.2000, p.22), Directive 2001/104/EU (OJ No. L.6, 10.1.2002, p.50) and Directive 2007/47/EC (OJ No. L.247, 21.9.2007, p.21).

[^c21293801]: Directive 98/79/EC was amended by Regulation (EC) No 1882/2003 (OJ No. L.284, 31.10.2003, p.1), Regulation (EC) No. 596/2009 (OJ No. L.188, 18.7.2009, p.14) and Directive 2011/100 (OJ No. L.341, 22.12.2011, p.50) and was corrected by Corrigendum (OJ No. L.22, 29.1.1999, p.75) and Corrigendum (OJ No. L.6, 10.1.2002, p.70).

[^key-bd6db54f7b32aa88d9db67f062974c82]: Reg. 3 revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 22