New role for EMA in MDR and IVDR

At last night’s DDC discussion with Janine Jamieson and others we talked about a new Commission proposal for EMA that gives them a new role hosting and managing expert panels for IVDs and MDs.

Is this a welcome development or does it make devices regulation too onerous?

Steve Lee
ABHI
Director of Diagnostics Regulation
Stephen.lee@abhi.org.uk

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Hi Steve,

Thanks for sharing - I’m really interested in what others think about this when they have chance to read and digest it!

As we discussed, it makes sense to have a central ‘home’ for the MDCG expert group meetings and there is increasing convergence with medicines for sure - interesting to see how this will fit in with the EMA and EU network Strategy to 2025, as well as CAMD work. Some clear boundaries and remits will be needed I think!

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