The European Commission has just published in its Official Journal a text named “Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure”.

This document provides guidance for expert panels on the criteria used to decide whether or not to provide a scientific opinion on the clinical evaluation assessment report drawn up by the notified body.

This decision is taken within 21 days, under the supervision of the Commission, on the basis of criteria defined in this text.


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