Template for the notification of serious adverse events (SAE) and device deficiencies to the ethics committees for clinical investigations with medical devices.

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European reporting form for the notification of serious adverse events (SAE) to the ethics committees for conformity-related multi-centre clinical trials with medical devices in sub-categories C1 and C2 that are also being conducted abroad (art. 33 lit. 3 ClinO-MD)

Completion instructions of the reporting form MDGC 2020-10/2 are given in chapter 10 of the European guidance document MDCG 2020-10/1 (link).

Do not use this reporting form to notify SAEs occurring in Switzerland if the clinical trial is only conducted in Switzerland.