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6 juillet 2008
Breaking News:

La Commission souhaite sonder le marché des dispositifs médicaux[en

Publié: vendredi 9 mai 2008   

Face à la pléthore de directives qui réglementent actuellement le marché des dispositifs médicaux comme les seringues ou les pacemakers, la Commission a lancé une consultation pour rationaliser la législation dans ce domaine.

There have been nine EU directives on this since 1990, covering everything from active implantable devices to in-vitro diagnostic devices. But these are deemed too splintered and complicated and are implemented to varying degrees by the member states. 

The Commission has therefore asked stakeholders to assess the current directives in a consultationexternal announced on 8 May. One of the main aims is to assess effects on health and safety standards for patients and healthcare professionals alike. 

With Europe holding a third of the global medical devices market, Enterprise and Industry Commissioner Günter Verheugen believes the existing legislation needs simplifying to preserve the "right conditions for innovation and competitiveness in the medical device industry". 

Eucomed, the European medical devices association, welcomedexternal the Commission's proposal for a consultation, reaffirming its insistence that all medical devices be subject to the directive. 

The consultation process is set to close in early July 2008, with new legislation expected during the course of 2009. 

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