Europe – European Commission provides latest figures on Notified Body MDR, IVDR designations

More than 85% of European Notified Bodies currently operating have applied for designation to the Medical Devices Regulation (MDR), while half of all Notified Bodies now supporting CE Marking for IVD manufacturers have applied for designation to the In-vitro Diagnostic Medical Devices Regulation (IVDR).

According to an update from the European Commission, 44 applications from Notified Bodies for MDR designation have been submitted as of January 2020, four months before the Regulation’s May 2020 application date. In addition, 11 applications for IVDR designation have been submitted so far, two years out from that Regulation’s May 2022 compliance deadline…