Following the PIP scandal (See our GMP News from 22. February) the EU currently deals more intensively with the planned revision of medical devices regulation. In a resolution the European Parliament has now proposed various measures to eliminate the "system's malfunctions on a European and a national level". The following measures are currently being discussed:
The EU Commission with commissioner Dalli is objecting to the first measure. For the commission the introduction of an "authorisation system" bears the risk of an "overregulation" for medical devices that would also impede innovations. Dalli instead prefers a more stringent market monitoring. It will be interesting to see in what direction medical devices regulation will move.
More details with regard to the parliamentarians' suggestions are available in the EU press release "Breast implants: Parliament proposes stricter safety checks."
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)