Category European Union

CMDh updates April 2021

CMDh Minutes for the meeting on 23-25 March 2021 The minutes from this meeting are available here. List of safety concerns per approved Risk Management Plan (RMP) of active substances per product  The updated list is available here. RMS Validation…

Commission implementing decision on standardisation requests to CEN and Cenelec for medical devices in support of the MDR and IVDR regulations

In April 2021, the Commission implementing decision on standardisation requests to the European Committee for Standardisation (CEN) and European Committee for Electrotechnical Standardisation (Cenelec) for medical devices in support of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/745 (IVDR). About…

CMDh updates March 2021

List of safety concerns per approved Risk Management Plan (RMP) of active substances per product  This list updated in March 2021 is available here. Updated Lead Member State PSUR Follow-Up assessment report template This template is available here. Updated List of active…