Template from Swissmedic for the notification of serious adverse events (SAE) and device deficiencies to the ethics committees for IVD devices clinical performance studies.

Template requires Adobe Acrobat Reader. Download the template first, if it does not open directlty in the Browser.

European reporting form for the notification of serious adverse events (SAE) to the ethics committees for conformity-related multi-centre IVD devices clinical performance studies 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 2024-4 Appendix are given in chapter 11 of the European guidance document MDCG 2024-4 (link).

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