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Image header Agence Europe
Europe Daily Bulletin No. 9016
Contents Publication in full By article 21 / 30
GENERAL NEWS / (eu) eu/health

30/08/2005 (Agence Europe) - On 11 August 2005, the European Commission adopted a directive reclassifying prosthetic hip, knee and shoulder joints under the directive 93/42/EEC on medical devices. This decision, which comes in response to a request by France and the United Kingdom, will move these prosthetics from class IIb to class III in order to tighten up assessment procedures for conformity. These prosthetics, which are particularly complex in nature, must in both cases be able to support the weight of the body and in the third, the dynamic forces of similar intensity. This new level of safety should allow both the risks associated with implant operations and the number of surgical operations to be reduced. The directive was published in the Official Journal L 210 of 12 August 2005.

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