Jan 28, 2020

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.

Actual MDR designations as of January 2020

Although most Notified Bodies now designated to issue CE Marking under the European Medical Devices Directives have begun the work of obtaining designation under the MDR, the number of Notified Bodies actually designated to the Regulation and whose designation data has been entered into the European NANDO database has only recently climbed into the double digits: 12 official designations, plus nine NANDO entries as of January 21, 2020. (Three additional Notified Bodies’ designation information is awaiting publication in NANDO, according to the EC report.)

With several Notified Bodies still in the process of obtaining designation to the MDR, concerns about these organizations’ capacity to support medical device manufacturers’ European certification requirements past the May 2020 compliance deadline remain well-founded. The fact that so many Notified Bodies are now undergoing review for designation, plus the fairly steady clip at which European authorities have issued such designations in recent months, may help mitigate these concerns over the near term.

Learn more about European MDR and IVDR regulatory issues: