The Medical Devices (Amendment) Regulations 2003

Made: 4th July 2003

Laid before Parliament: 11th July 2003

Coming into force

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 of the powers conferred by section 11 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:

Citation, commencement and interpretation

1

• (1) These Regulations may be cited as the Medical Devices (Amendment) Regulations 2003 and shall come into force—

• (a) except for the purposes of regulations 3(b), 6, 7 and 9, on 1st September 2003; and

• (b) for the purposes of regulations 3(b), 6, 7 and 9, on 1st April 2004.

• (2) In these Regulations, the “principal Regulations” means the Medical Devices Regulations 2002 .

Amendment of regulation 2 of the principal Regulations

2

In regulation 2(1) of the principal Regulations (interpretation)—

• (a) the words “, unless the context otherwise requires” are omitted;

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) after the definition of “Directive 2001/83”, there is inserted the following definitions—

“Directive 2003/12” means Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices; ...

• (d) in the definition of “the Medical Devices Directives”, after “Directive 93/42” there is inserted “ , read with Directive 2003/32 ”;

• (e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (f) in the definition of “notified body”, for “Part V of” there is substituted “ Part V or ”; and

• (g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of regulation 4 of the principal Regulations

3

In regulation 4 of the principal Regulations (transitional provisions)—

• (a) after paragraph (4) there is inserted the following paragraph—

(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).

; and

• (b) after paragraph (5) there shall be added the following paragraph—

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

Amendment of regulation 5 of the principal Regulations

4

In regulation 5(1) and (2) of the principal Regulations (interpretation of Part II), the words “, unless the context otherwise requires” are omitted.

Amendment of regulation 7 of the principal Regulations

5

In regulation 7 of the principal Regulations (classification of general medical devices), after “Directive 93/42”, at both places where this occurs, there is inserted “ , read with Directive 2003/12 ”.

Amendment of regulation 13 of the principal Regulations

6

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Amendment of regulation 17 of the principal Regulations

7

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Amendment of regulation 18 of the principal Regulations

8

In regulation 18 of the principal Regulations (UK notified bodies and the conformity assessment procedures for general medical devices), after paragraph (3) there is added the following paragraph—

(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.

New regulation 19A of the principal Regulations

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of regulation 20 of the principal Regulations

10

In regulation 20 of the principal Regulations (interpretation of Part III)—

• (a) in paragraphs (1) and (2) the words “, unless the context otherwise requires” are omitted;

• (b) in paragraph (2), the words “article or”, at both places where they occur, are omitted.

Amendment of regulation 32 of the principal Regulations

11

In regulation 32(1) and (2) of the principal Regulations (interpretation of Part IV), the words “, unless the context otherwise requires” are omitted.

New regulation 44A of the principal Regulations

12

In Part V of the principal Regulations (notified bodies, conformity assessment bodies and marking of products), before regulation 45 (designation etc. of UK notified bodies) there is inserted the following regulation—

(44A) In this Part, “medical device” means a device that is a “relevant device” for the purposes of Part II, III or IV.

Amendment of regulation 45 of the principal Regulations

13

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Amendment of regulation 47 of the principal Regulations

14

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Amendment of regulation 52 of the principal Regulations

15

In regulation 52(1) of the principal Regulations (interpretation of Part VI), the words “, unless the context otherwise requires” are omitted.

Amendment of regulation 54 of the principal Regulations

16

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Amendment of regulation 59 of the principal Regulations

17

In regulation 59 of the principal Regulations (interpretation of Part VII), the words “, unless the context otherwise requires” are omitted.

Signed

Signed by authority of the Secretary of State for Health

Warner — Parliamentary Under-Secretary of State, — Department of Health — 2003-07-04

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 1972 c. 68.

[^f00002]: 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.

[^f00003]: 1987 c. 43.

[^f00004]: S.I. 2002/618.

[^f00005]: OJ No. L 28, 4.2.2003, p.43.

[^f00006]: OJ No. L 169, 12.7.1993, p.1; 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) and Directive 2001/104/EC (OJ No. L 6, 10.1.2002, p.50).

[^f00007]: OJ No. L 105, 26.4.2003, p.18.

Editorial notes

[^c5210461]: 1972 c. 68.

[^c5210471]: 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.

[^c5210481]: 1987 c. 43.

[^c5210491]: S.I. 2002/618.

[^c5210501]: OJ No. L 28, 4.2.2003, p.43.

[^c5210511]: OJ No. L 169, 12.7.1993, p.1; 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) and Directive 2001/104/EC (OJ No. L 6, 10.1.2002, p.50).

[^key-e1ff895a0d70199884ae2f99467b3465]: Reg. 2(b) revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(a)

[^key-69ec67742f61f0e412b9d79b33592cab]: Words in reg. 2(c) revoked (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(a)

[^key-1ce0097979144acc693e3198cde7ad46]: Reg. 2(e) revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(a)

[^key-33f1cd3e356665554c13c91e4419abc4]: Reg. 2(g) revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(a)

[^key-cf6fceb81b56b0afe4d4abe9a5d33413]: Reg. 6 revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(b)

[^key-f1e40a9c45d5a18a840d5684c8d00fc0]: Reg. 7 revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(c)

[^key-b41f305c1d97e6fcc843f635749d699d]: Reg. 9 revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(d)

[^key-79c349259191ae5c6d91fcbb7c80a160]: Reg. 13 revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(e)

[^key-ed8db0d1bf5468cfc66f4586dedce68f]: Reg. 14 revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(f)

[^key-3061e4acb160c9b6e21e4a263bd79dcd]: Reg. 16 revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(g)