The Medical Device Coordination Group (MDCG) is very active in May 2020 with the publication of MDCG 2020-10 on 13 May.

Part 1 (MDCG 2020-10 / 1 « Safety Reporting in Clinical Investigations of MD Under the Regulation (EU) 2017 / 745 »)  discusses how to record and report adverse events occurring in the context of a clinical investigation conducted under MDR (Medical Devices Regulation 2017/745) pending EUDAMED.

For PMCF clinical studies conducted in accordance with Article 74 of MDR, this guide applies only if a causal link has been established between serious adverse event and investigational procedure preceding it. Otherwise, the provisions on vigilance laid down in Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply (refer to Article 80.5 and 6 of MDR).

The 2nd document (MDCG 2020-10/2 Clinical Investigations Summary Safety Report Form v1.0) is a template model to be filled for reporting.