EC adopts proposal to allow more time to certify medical devices 23 Jan 2023

Fears of a shortage of medical devices have led the European Commission (EC) to adopt a proposal to extend the transition period to new rules under the Medical Devices Regulation. The proposal was made at the EPSCO Council meeting on 9 December 2022 by EU health ministers.

The length of the proposed extension depends on the type of device, higher risk devices having a shorter transition period (until December 2027) than medium and lower risk ones (until December 2028).

The proposal now needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.

More details via the link.