EU Proposes Giving Low-Risk Devices More Time to Comply With Regulations

The EU proposes to allow low-risk Class I devices four more years to comply with the EU Medical Device Regulation.

The Council of the European Union’s latest set of corrections for the EU MDR would extend the compliance date for low-risk Class I devices to May 26, 2024.

The proposed revision would clarify that Class I devices that need a conformity assessment for CE marking and had a conformity assessment conducted before May 26, 2020 could be placed in the market until May 26, 2024.