State-of-play of NB designations

The European Commission (EC) published a document on the state-of-play of designation process of Notified Bodies under the MDR and IVDR:

44 applications received for the accreditation under the MDR
• 3 new applicants (1 of them withdrew)
• 40+1 out of 49 current* bodies – 86%

11 applications received for the accreditation under the IVDR
• 1 new applicant
• 10 of 20 current* bodies – 50%
* Designated under the Directives, excluding bodies from Turkey

The EC DG SANTE also received 49 Preliminary Assessment Reports (40 under the MDR and 9 under the IVDR).

Out of 49 on-site assessments, there are still pending assessments for 2 MDR applicants and 2 IVDR applicants.

You can see below the current status of Notified Body accreditation under the MDR and IVDR – per step of the process [Source European Commission]:

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