Directive 2005/50 - Reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices - Main contents
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official title
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| Legal instrument | Directive |
|---|---|
| Number legal act | Directive 2005/50 |
| CELEX number i | 32005L0050 |
| Document | 11-08-2005 |
|---|---|
| Publication in Official Journal | 18-10-2006; OJ L 210, 12.8.2005,OJ L 287M , 18.10.2006,Special edition in Croatian: Chapter 13 Volume 055,Special edition in Bulgarian: Chapter 13 Volume 049,Special edition in Romanian: Chapter 13 Volume 049 |
| Effect | 01-09-2005; Entry into force Date pub. + 20 See Art 5 |
| End of validity | 31-12-9999 |
| Transposition | 01-03-2007; At the latest See Art 4.1 |
12.8.2005 |
EN |
Official Journal of the European Union |
L 210/41 |
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)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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 request submitted by France and the United Kingdom,
Whereas:
(1) |
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. |
(2) |
France 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. |
(3) |
Conformity 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. |
(4) |
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. |
(5) |
Hip, knee and shoulder replacements should be distinguished from other total joint replacements, due to the particular complexity of the joint function to be restored and the consequent increased risk of failure due to the device itself. |
(6) |
In particular, hip and knee replacements are weight-bearing and extremely sophisticated implants, for which the risk of revision surgery is significantly greater than for other joints. |
(7) |
Shoulder implants are a more recent technique, which are subject to similar dynamic forces; their possible replacement is in principle connected with serious medical problems. |
(8) |
Furthermore, hip, knee and shoulder replacement surgery is increasingly taking place on young people with a high life expectancy; consequently, the need for such implants to function properly over the life expectancy of the patients and to reduce revision surgery and its risks has been increased. |
(9) |
Specific clinical data, including long term performance data are not always available for hip, knee and shoulder replacements before they are placed on the market and put into service; consequently, conclusions on clinical data collected by the manufacturer in the framework of the evaluation of the conformity of these products with the requirements concerning their characteristics and performance referred to in Sections 1 and 3 of Annex I to Directive 93/42/EEC should be subject to particular attention and examination in order to verify the appropriateness of the clinical data available. |
(10) |
Total joint replacements can be subject to multiple modifications following their introduction into clinical use and placing on the market, as shown by hip and knee replacements on the market. However, experience has shown that what appear at first sight to be minor post-marketing changes to the design of previously trouble-free replacements can lead to serious problems due to unintended consequences, which may lead to early failure and major safety concerns. |
(11) |
In order to achieve the optimal level of safety and health... |
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