Amendment to Regulation (EU) 2022/123 (+1 more) on medical devices and in vitro diagnostic medical devices
COMCMT1R-EP1R-C2R-EPCNCADO
Updated 26d ago
This procedure aims to simplify and reduce the regulatory burden associated with medical devices and in vitro diagnostic medical devices. It seeks to make the rules more manageable for manufacturers and ensure continued access to these essential products for patients.
The changes will affect manufacturers of medical devices and in vitro diagnostic medical devices, potentially leading to faster market access. The European Medicines Agency's support for expert panels is also being adjusted.