Third standards mandate ready by Q1 2021, says Commission

Following two failed attempts to have its standards mandate for the Medical Devices Regulation (MDR, 2017/745) accepted by the European standards bodies CEN and CENELEC, the European Commission has indicated that a third mandate will be issued during the first quarter of 2021.

The new date has been included in the recently updated Joint Implementation Plan, which now states under the heading of ‘Standardisation’: “Adopted on 15 May, rejected by CEN/CENELEC on 16 June. New procedure to be launched for possible adoption from Q1 2021.”

The main stumbling block for acceptance and adoption of the mandate appears to be linked to the European bodies’ desire to maintain consistency with the international standards developed by ISO and IEC, rather than have slightly different versions for European compliance, which would be necessary if the rejected mandates had been adopted.