#medicaldevicesregulation

EC adopts proposal to allow more time to certify medical devices

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.

23 Jan 2023

European Council backs delay to Medical Devices Regulation (MDR) deadlines

The Regulatory Affairs Professionals Society (RAPS) reports that the European Council supports a proposal made by the European Commission to delay the transitional deadlines for medical devices under the MDR.

12 Dec 2022