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IVDR knowledge center

On the pages of the IVDR Knowledge Center IVDR you can find important and relevant information about the new regulation that will come into force for in vitro diagnostics from 26 May 2022, and what consequences this may have for you.

by Steven Boom, LL.M., Quality Assurance Manager at diagnotix

From our contacts with laboratories throughout the Netherlands, we notice that there is still a lot of uncertainty about the consequences of the introduction of the IVDR in 2022. As an IVD manufacturer, the IVDR is one of our top priorities. diagnotix • •• already wants to comply with the regulations for 2022. We are happy to make our knowledge of this complex subject available to you. If you have any questions about the IVDR, please do not hesitate to contact us.

FAQ IVDR: CE certification IVDR: Validation IVDR in practice

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