Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (Text with EEA relevance)
Date: 2003-02-03
Institutions: European Commission
Subjects: European standard, marketing, medical device, surgery, woman

4.2.2003

EN

Official Journal of the European Union

L 28/43

COMMISSION DIRECTIVE 2003/12/EC

of 3 February 2003

on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning
medical devices

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

HAS ADOPTED THIS DIRECTIVE:

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 93/42/EEC of 14 June 1993
concerning medical devices (1), as last amended by Directive
2001/104/EC of
the
Council (2), and in particular Article 13(1)(b) thereof,

the European Parliament

and of

Article 1

By way of derogation from the rules set out in Annex IX to
Directive 93/42/EEC, breast implants shall be reclassified as
medical devices falling within Class III.

Having regard to the request submitted by France and the
United Kingdom,

Whereas:

Article 2

On the basis of
to
Annex IX to Directive 93/42/EEC, breast implants are in
principal Class IIb medical devices.

the classification criteria set out

1.
Breast implants placed on the market before 1 September
2003 pursuant to Article 11(3)(a) or 11(3)(b)(iii) of Directive
93/42/EEC shall be subject to a conformity reassessment proce-
dure as Class III medical devices before 1 March 2004.

(1)

(2)

(3)

(4)

(5)

France and the United Kingdom requested the classifica-
tion of breast implants as Class III medical devices by
way of derogation from the provisions of Annex IX to
Directive 93/42/EEC.

In order to ensure the highest possible level of safety for
breast implants, notified bodies should, under the full
quality assurance system, carry out an examination of
the design dossier of the product in accordance with
point 4 of Annex II to Directive 93/42/EEC. Conse-
quently, it is necessary to proceed to the reclassification
of breast implants as Class III medical devices.

It is necessary to determine the regime applicable to
breast
implants placed on the market before 1
September 2003 under Article 11(3)(a) or 11(3)(b)(iii) of
Directive 93/42/EEC.

The measures provided for in this Directive are in accor-
dance with the opinion of the Committee on Medical
Devices set up by Article 6(2) of Council Directive 90/
385/EEC of 20 June 1990 on the approximation of the
laws of the Member States relating to active implantable
medical devices (3), as last amended by Directive 93/68/
EEC (4),

(1) OJ L 169, 12.7.1993, p. 1.
(2) OJ L 6, 10.1.2002, p. 50.
(3) OJ L 189, 20.7.1990, p. 17.
(4) OJ L 229, 30.8.1993, p. 1.

2.
By way of derogation from Article 11(11) of Directive
93/42/EEC, the decisions on breast implants taken by the noti-
fied bodies before 1 September 2003 under Article 11(3)(a) of
Directive 93/42/EEC may not be extended.

Article 3

1. Member States shall adopt and publish the laws, regula-
tions and administrative provisions necessary to comply with
this Directive, not later that 1 August 2003. They shall immedi-
ately inform the Commission thereof.

When Member States adopt these provisions, they shall contain
a reference to this Directive or shall be accompanied by such a
reference at the time of their official publication. The procedure
for such reference shall be adopted by the Member States.

Member States shall apply these measures with effect from 1
September 2003.

2. Member States shall communicate to the Commission the
texts of the provisions of national law which they adopt in the
field covered by this Directive.

L 28/44

EN

Official Journal of the European Union

4.2.2003

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 3 February 2003.

For the Commission

Erkki LIIKANEN

Member of the Commission