Since the PIP scandal (see our GMP-News from 22. February 2012), the EU has been working on strengthening the planned revision of the Medical Devices Guidelines. The European Parliament has proposed different measures in a resolution to get rid of the "malfunctioning of the system at European and national levels". Following measures are being discussed:
The EU Commission addresses the first topic to its commissioner Dalli. It sees the introduction of an "authorisation system" dangerous because of over-regulation and connected inhibition for innovations. Instead, Dalli recommends stronger market monitoring. It will be interesting to see how development of medical devices regulations will evolve.
Details about the parliamentarians' proposals can be found in a press release of the EU.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)