MDCG: industry is not part of and does not vote

M

mgloria

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Context

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MDR Art. 103 establishes a Medical Device Coordination Group (MDCG) and its tasks are clarified in Art. 105. Only CAs appointed members are part of it (so not the industry or NBs) but Art 105.7 establishes sub-groups where industry can for instance participate as a non-voting member. Moreover, the MDCG effectively substitutes the Medical Device Expert Group (MDEG) of which industry was part.

Question
Did industry used to vote in MDEG? Is it a right that has been lost under the MDR or the situation has not changed significantly?

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