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:

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From 20 Team-NB notified bodies members,

8 are in the designation process,

3 will apply later and

9 will not apply.

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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;

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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.

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