![]() Reclassification by derogation to the classification rules set out in Annex IX to Directive 93/42/EEC is indicated where the shortcomings identified due to the specific characteristics of a product will be more properly addressed under the conformity assessment procedures corresponding to the new category. On the basis of the classification rules set out in Annex IX to Directive 93/42/EEC, total joint replacements are class IIb medical devices.įrance and the United Kingdom requested the classification of total joint replacements as class III medical devices by way of derogation from the provisions of Annex IX to Directive 93/42/EEC, in order to ensure an appropriate conformity assessment of total joint replacements before their placing on the market.Ĭonformity assessment is based on a number of elements such as a proper classification, the designation and monitoring of the notified bodies and the proper implementation of the conformity assessment modules as described in Directive 93/42/EEC. Having regard to the request submitted by France and the United Kingdom, Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 1), and in particular Article 13(1)(b) thereof, Having regard to the Treaty establishing the European Community, THE COMMISSION OF THE EUROPEAN COMMUNITIES, On the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices 155 - 157 Special edition in Croatian: Chapter 13 Volume 055 P. 155 - 157 Special edition in Romanian: Chapter 13 Volume 049 P. ![]() (MT) Special edition in Bulgarian: Chapter 13 Volume 049 P. (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV) OJ L 287M, , p. 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)
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