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:

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• 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.”

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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.