Update on received NB Applications by the EC

The European Commission has published the State-of-play on the designation process of Notified Bodies (NBs) under the MDR/IVDR at the date of 9 October 2018.

Since the last State-of-play in June this year, 5 more NBs applied under the MDR, however no new application was received for NB designation under the IVDR.

Until this date,

  • The EC received 33 Applications from NBs (26 NBs applied under the MDR, and 7 NBs under the IVDR);

  • The EC received 22 Preliminary Assessment Reports from the “designating authority” (17 MDR, 5 IVDR);

  • 22 Joint Assessments have been/will be scheduled until January 2019;

  • 2 JAT opinions are under preparation.

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