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Statutory Instruments

2003 No. 1697

CONSUMER PROTECTION

The Medical Devices (Amendment) Regulations 2003

Made

4th July 2003

Laid before Parliament

11th July 2003

Coming into force

except for the purposes of regulations 3(b), 6, 7 and 9

1st September 2003

for the purposes of regulations 3(b), 6, 7 and 9

1st April 2004

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 M1 in relation to measures relating to medical devices M2, 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 M3 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:

Marginal Citations

M2The 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.

Citation, commencement and interpretationU.K.

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 M4.

Marginal Citations

Amendment of regulation 2 of the principal RegulationsU.K.

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

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

F1(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

““Directive 2003/12” means Commission Directive 2003/12 M5 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC M6 concerning medical devices;

F2...”;

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

F3(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

F4(g). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2Words 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)

Marginal Citations

M5OJ No. L 28, 4.2.2003, p.43.

M6OJ 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).

Amendment of regulation 4 of the principal RegulationsU.K.

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 RegulationsU.K.

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 RegulationsU.K.

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 RegulationsU.K.

F56.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 17 of the principal RegulationsU.K.

F67.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 18 of the principal RegulationsU.K.

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 RegulationsU.K.

F79.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 20 of the principal RegulationsU.K.

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 RegulationsU.K.

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 RegulationsU.K.

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—

“Interpretation of Part V

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 RegulationsU.K.

F813.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 47 of the principal RegulationsU.K.

F914.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 52 of the principal RegulationsU.K.

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 RegulationsU.K.

F1016.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Amendment of regulation 59 of the principal RegulationsU.K.

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

Signed by authority of the Secretary of State for Health

Warner

Parliamentary Under-Secretary of State,

Department of Health

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Medical Devices Regulations 2002 (“the principal Regulations”), which contain the legislative measures necessary for the implementation of the European Community scheme for regulating the placing on the market and putting into service of medical devices. The amendments include amendments that are necessary for the implementation of Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants within the framework of Directive 93/42/EEC on medical devices (“Directive 2003/12”) and Commission Directive 2003/32 of 23rd April 2003 on medical devices utilising tissues of animal origin (“Directive 2003/32”).

Regulation 2 introduces new definitions into the principal Regulations, and amends another definition to take account of Directive 2003/32.

Regulation 5 requires breast implants to be reclassified as Class III devices, from Class IIb. Regulation 3(a) delays the effect of this reclassification by six months for products already on the market on 1st September 2003. Regulation 8 prevents notified bodies from extending earlier decisions on breast implants, taken on the basis that they were Class IIb devices, for longer than Directive 2003/12 allows.

Regulations 6, 7 and 9 set new conditions relating to the manufacture and supply of general medical devices manufactured utilising tissues of animal origin. Regulation 3(b) delays the application of these new requirements in relation to devices placed on the market before 1st April 2004.

Regulation 12 inserts a new definition for the purposes of Part V of the principal Regulations to ensure that the requirements relating to the incorrect marking of products cover all the products that may be incorrectly marked with a notified body number, conformity assessment body number or CE marking.

Regulation 13 amends the scheme for designating bodies as notified bodies to take account of the extension, by virtue of Directive 2003/32, of the tasks for which notified bodies may be designated, and regulation 16 makes a consequential amendment to the fees provisions. Regulation 14 includes new obligations on notified bodies when evaluating devices manufactured utilising tissues of animal origin.

Regulation 2(a) and (f)—and also regulations 4, 10, 11, 15 and 17—correct drafting errors in the principal Regulations.

Regulatory Impact Assessments in relation to these Regulations, and a Transposition Note in relation to the implementation of Directives 2003/12 and 2003/32, have been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines and Healthcare products Regulatory Agency, Hannibal House, Elephant and Castle, London SE1 6TQ.