The MDCG has endorsed a guidance providing clarification on the conditions and corresponding procedures notified bodies need to apply when determining if an expert panel consultation on the performance evaluation report of the manufacturer is necessary for a class D in vitro diagnostic medical device, according to Article 48(6) of Regulation (EU) 2017/746.
According to the IVDR, the conditions are:
- The absence of common specifications for the class D device in question, AND
- If . . .
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