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Friday, October 18th

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MDCG 2024-11 guidance on qualification of in vitro diagnostic medical devices

On October 8, 2024, the MDCG published a guidance that clarifies what products fall in the scope of Regulation (UE) 2017/746 (IVDR). This document first lists general principles of qualification and then provides non-exhaustive lists of examples of IVDs and accessories to IVDs.

DOWNLOAD GUIDANCE MDCG 2024-11

MDCG 2024-11 guidance on qualification of in vitro diagnostic medical devices

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