Directive 2003/12 - Reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices

Please note

This page contains a limited version of this dossier in the EU Monitor.

1.

Current status

This directive has been published on February  4, 2003, entered into force on the same day and should have been implemented in national regulation on August  1, 2003 at the latest.

2.

Key information

official title

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
 
Legal instrument Directive
Number legal act Directive 2003/12
CELEX number i 32003L0012

3.

Key dates

Document 03-02-2003
Publication in Official Journal 04-02-2003; Special edition in Lithuanian: Chapter 13 Volume 031,Special edition in Romanian: Chapter 13 Volume 039,Special edition in Croatian: Chapter 13 Volume 064,Special edition in Slovenian: Chapter 13 Volume 031,Special edition in Latvian: Chapter 13 Volume 031,Special edition in Slovak: Chapter 13 Volume 031,Special edition in Czech: Chapter 13 Volume 031,Special edition in Hungarian: Chapter 13 Volume 031,OJ L 28, 4.2.2003,Special edition in Maltese: Chapter 13 Volume 031,Special edition in Bulgarian: Chapter 13 Volume 039,Special edition in Polish: Chapter 13 Volume 031,Special edition in Estonian: Chapter 13 Volume 031
Effect 04-02-2003; Takes effect Date notif.
End of validity 31-12-9999
Transposition 01-08-2003
Notification 04-02-2003; {titleAndReference.draft.disclaimer.new|http://publications.europa.eu/resource/authority/fd_365/titleAndReference.draft.disclaimer.new}

4.

Legislative text

Avis juridique important

|

5.

32003L0012

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)

Official Journal L 028 , 04/02/2003 P. 0043 - 0044

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,

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 European Parliament and of the Council(2), and in particular Article 13(1)(b) thereof,

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

Whereas:

  • (1) 
    On the basis of the classification criteria set out to Annex IX to Directive 93/42/EEC, breast implants are in principal Class IIb medical devices.
  • (2) 
    France and the United Kingdom requested the classification of breast implants as Class III medical devices by way of derogation from the provisions of Annex IX to Directive 93/42/EEC.
  • (3) 
    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. Consequently, it is necessary to proceed to the reclassification of breast implants as Class III medical devices.
  • (4) 
    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.
  • (5) 
    The measures provided for in this Directive are in accordance 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),

HAS ADOPTED THIS DIRECTIVE:

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.

Article 2

  • 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 procedure as Class III medical devices before 1 March 2004.
  • 2. 
    By way of derogation from Article 11(11) of Directive 93/42/EEC, the decisions on breast implants taken by the notified 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, regulations and administrative provisions necessary to comply with this Directive, not later that 1 August 2003. They shall immediately 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.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 3 February 2003.

For the Commission

Erkki Liikanen

Member of the Commission

  • (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...

More

This text has been adopted from EUR-Lex.

 

6.

Sources and disclaimer

For further information you may want to consult the following sources that have been used to compile this dossier:

This dossier is compiled each night drawing from aforementioned sources through automated processes. We have invested a great deal in optimising the programming underlying these processes. However, we cannot guarantee the sources we draw our information from nor the resulting dossier are without fault.

 

7.

Full version

This page is also available in a full version containing the legal context, de Europese rechtsgrond, other dossiers related to the dossier at hand and the related cases of the European Court of Justice.

The full version is available for registered users of the EU Monitor by ANP and PDC Informatie Architectuur.

8.

EU Monitor

The EU Monitor enables its users to keep track of the European process of lawmaking, focusing on the relevant dossiers. It automatically signals developments in your chosen topics of interest. Apologies to unregistered users, we can no longer add new users.This service will discontinue in the near future.