Proposal for IVDR extension also impacts MDR, EUDAMED

As many have been expecting, the Commission just proposed a second extension to the transitional period of the European IVD regulation, in response to manufacturer data showing marked unpreparedness, along with continued delays in rolling out tools like EUDAMED that are needed to implement the regulation. But medical device manufacturers also need to take a look at the proposal, since it would affect them, too.

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