Article 1
By way of derogation from the rules set out in Annex IX to Directive 93/42/EEC, hip, knee and shoulder replacements shall be reclassified as medical devices falling within class III.
Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance)
Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council 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
For the purpose of this Directive, a hip, knee or shoulder replacement means an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint. Ancillary components (screws, wedges, plates and instruments) are excluded from this definition.
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.
Article 4
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 March 2007. They shall immediately inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. Member States shall determine how such a reference is to be made. Member States shall apply those provisions from 1 September 2007. 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 5
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union .
Article 6
This Directive is addressed to the Member States.
Implementing measures in the Member States
Transposition links come from the Member States’ notifications published on EUR-Lex. Only high-confidence matches held on LawPlayer are listed; see EUR-Lex for the complete list.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
What to look at next
Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislationEU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and yearEuropean Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview