With a plethora of directives currently regulating the market for medical devices such as syringes and pacemakers, the Commission has launched a consultation to streamline legislation in this area.
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 consultation 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, welcomed 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.