Serious adverse events (SAE), medical devices

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

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

English
3.2
updated: 01.10.2022

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.

English
1.0
updated: 06.12.2022

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

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

English
3.3
updated: 01.10.2022