Article 1
Open ↗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.
Source
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)
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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
Open ↗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
Open ↗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
Open ↗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.
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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