The recording and reporting to competent authorities of adverse events occurring during performance studies of in vitro diagnostic medical devices (IVDs) must be conducted in accordance with Article 76 of Regulation (EU) 2017/746.

Published by the Medical Device Coordination Group (MDCG), this guidance outlines the reporting modalities, including the scope, methodologies, timelines, types of events to report, guidelines, and stakeholders involved. This guidance is accompanied, in annex, by a form to be used by the sponsor or their delegate to report events to the competent authorities.



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