NoBoCap: Is Structured Dialogue The Key to Unlocking Medtech Innovation?

European Commission acts on call from industry for more guidance from notified bodies around innovation.

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The European Commission’s medical devices unit explained at the recent NoBoCap Community meeting in Brussels that it aims to define more precisely the types of exchanges that can occur within the context of “structured dialogue” between notified bodies and their clients before and during the conformity assessment process.

Its goal is to enhance the efficiency and predictability of the conformity assessment process.

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