Improving the safety of medical devices

The European Commission has adopted two measures for implementation to improve the safety of medical devices.

The new rules are a Commission Implementation Regulation clarifying the criteria to be met by notified bodies, which are responsible for inspecting manufacturers of medical devices, and a Recommendation clarifying the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector.

For further details, see the following press release.

Posted by Tim Sandle