Amendment: Re-assessment frequency for notified bodies (Reg 2017/746)
COMCMT1R-EP1R-C2R-EPCNCADO
Updated 45mo ago
This procedure updates the rules for how often notified bodies, which assess medical devices, must undergo full re-assessments. It aims to ensure ongoing compliance and safety standards for these critical organizations.
Manufacturers of medical devices and the notified bodies themselves will be most affected. The change impacts the regularity of oversight, potentially streamlining processes while maintaining rigorous safety checks.