On 5 December 2008 the European Commission, Directorate General Enterprise and Industry, published the results of the public consultation on the planned recast of the medical devices directive on its web site:
Between 8 May and 2 Jul 2008 the European Commission consulted stakeholders on the issue with the aim to modernise and simplify the legislation on medical devices.
The Commission received 200 responses, half of which came from industry. Most respondents confirmed that the current legal framework left some room for improvement, but considered the timing too premature with view to the recent revision of Directives 90/385/EEC and 93/42/EEC and the adoption on the New Legal Framework for the Marketing of Products. Regarding Notified Bodies, there was unanimous support for improving the way in which NBs work to ensure a uniform high level of competence. Many respondents, including NBs themselves, supported central oversight of their designation by Member States.
There have been nine EU directives on medical devices 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. One of the main aims was 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".
In a joint statement on 2 July 2008, the European Medical Device Industry associations COCIR, EDMA, EHIMA, EUCOMED, EUROMCONTACT, EUROM VI and FIDE, representing 95% of the medical device industry, expressed their concerns about the proposal which they think to be inappropriate at the moment.
“There is no substantiated evidence that there is a need for a centralised European agency for Medical Devices to take on a role in classification, pre-market approval of “highest risk” devices, Notified Bodies and post-market activities. The concerns raised by the EU Commission can be addressed through improved implementation of existing measures.”
Read the full joint position paper:
The revision of the medical devices directives is officially part of the Commission Work Programme for 2009.
The European Commission will carry out an impact assessment on the planned recast during the first half of 2009. In the frame of this impact assessment the Commission will consider the possible legislative approaches and the resulting costs and draft solutions.
A legislative proposal (directive, regulation or other) will be tabled in September 2009 at the earliest or possibly only after the new Commission will have taken up its work.
Read also the European Commission press release:
and the Eucomed press release:
For more information please contact Astrid Grunert, EU Affairs Manager: email@example.com