The European Commission has published an unofficial version of its new regulatory requirements for Notified Bodies that play a key role in CE Mark certification for medical devices.
Although the published requirements contain no reference numbers or dates, the document likely provides a clear indication of how Notified Bodies will have to comply.
In brief, Notified Bodies will face the following:
- Compulsory inspections by Competent Authorities every 18 months
- Notified Bodies with more than 100 clients will be inspected every 12 months
- European Commissioners have the power to investigate Notified Body competency and withdraw notification
- There will be a rather short three-month transition period for the new requirements
In related news, the European Parliament Environment, Public Health and Food Safety Committee (ENVI) has voted in favor of proposed warned would drive up costs significantly for industry participants—particularly small and medium-sized enterprises (SMEs).
Eucomed quickly denounced the ENVI draft laws as “almost Kafkaesque," financially burdensome to industry and unlikely to improve patient and user safety in Europe.
The full House of the EU Parliament will vote on the ENVI proposed laws in mid October 2013. Emergo Group will provide further details on these developments as we learn them.