European Commission has received 28 applications from NBs

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 30 June 2018:

  • The EC received 28 Applications from NBs (21 NBs applied under the MDR, and 7 NBs under the IVDR);

  • The EC received 19 Preliminary Assessment Reports from the “designating authority” (14 MDR, 5 IVDR)

  • 16 Joint Assessments have been already scheduled until 3 November 2018.

As the Article 39 of MDR states: ” The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, to be involved in the conformity assessment process.”

Other useful documents:

You can also consult the EC Information note on Joint Assessments here, and more detailed NBOG’s Best practice guide on designation and notification of conformity assessment bodies.

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