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)

• CELEX: Directive 2003/12/EC
• Articles: 4

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, 30.8.1993, p. 1.