IVDR: MDCG Guidance on Classification Rules for in vitro diagnostic medical devices released! -- MEDICA - World Forum for Medicine

16.11.2020

Obelis S.A. Obelis European Authorized Representative Center

IVDR: MDCG Guidance on Classification Rules for in vitro diagnostic medical devices released!

The MDCG published a very important document for all IVD manufacturers, as well as for notified bodies and health institutions, which shall provide guidance on the classification rules under the IVDR – Regulation (EU) 2017/746, namely its Annex VIII – while noting that the regulatory text and the MDCG Guidance shall be read jointly.

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