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Commission Directive 2005/50/EC of 11 August 2005 on the… Article 3

Commission Directive 2005/50/EC of 11 August 2005 on the… Article 3

Article 3

1.   Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 11(3)(a) of Directive 93/42/EEC before 1 September 2007 shall be subject to a complementary conformity assessment under point 4 of Annex II to Directive 93/42/EEC leading to an EC design examination certificate before 1 September 2009. This provision does not preclude a manufacturer from submitting an application for conformity assessment based on Article 11(1)(b) of Directive 93/42/EEC. 2.   Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to Article 11(3)(b)(iii) of Directive 93/42/EEC before 1 September 2007 may be subject to a conformity assessment as class III medical devices pursuant to Article 11(1)(b)(i) or (ii) before 1 September 2010. This provision does not preclude a manufacturer from submitting an application for conformity assessment based on Article 11(1)(a) of Directive 93/42/EEC. 3.   Member States shall accept until 1 September 2009 the placing on the market and the putting into service of hip, knee and shoulder replacements covered by a Decision in accordance with Article 11(3)(a) of Directive 93/42/EEC issued before 1 September 2007. 4.   Member States shall accept until 1 September 2010 the placing on the market of hip, knee and shoulder replacements which are covered by a Decision in accordance with Articles 11(3)(b)(iii) of Directive 93/42/EEC issued before 1 September 2007 and permit such total joint replacements to be put into service beyond that date.

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Other provisions in Commission Directive 2005/50/EC of 11 August 2005 on the…

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 3 of Commission Directive 2005/50/EC of 11 August 2005 on the… (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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