IVDR: Team-NB Survey on NB designation process

This time, Team-NB performed a survey on the designation process of Notified Bodies (NBs) under the IVDR and currently:

From 20 Team-NB notified bodies members,

8 are in the designation process,

3 will apply later and

9 will not apply.

And among the 15 non-members NBs,

4 are in the designation process,

6 will not apply and

2 have not made their decision yet;

Survey also reports more detailed status of the designation process, e.g.  4 Team-NB members already passed the Joint audit and are now addressing the observations; the scope of application, i.e. majority of NBs aims to apply for bigger scope and the number of currently valid IVDD Certificates.

Check more detailed analysis and related graphs on the following link.

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