Theme Clinical investigation
Target audience Sponsors (Manufacturer, Legal Representative or Contact Person)
Products concerned Investigational MD
Regulatory references MDR (EU) 2017/745

Article 80(2)


This document defines the modalities for reporting Serious Adverse Events (SAE) that occur during a clinical investigation, as long as EUDAMED is not fully functional.

It concerns both pre-market clinical investigations to establish the conformity of the MD before marketing and those concerning MD already bearing the CE mark under the post-market clinical follow-up (PMCF). Clinical investigations which have started to be conducted in accordance with MDD and AIMDD before May 26, 2021 are also concerned.

This guidance contains a table entitled “Overview of formats to be used by sponsors when reporting to national competent authorities” and the dates from which they should be used.

The form to be used for investigations carried out from May 26, 2021 onwards is notified in an annex, and can be found in a separate document, the MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form. This document will have to be completed and updated each time a SAE is reported, or for each update of previously reported events. It will be sent to all competent national authorities of the EU member states where the clinical investigation is being conducted ( as well as the competent authorities of Switzerland and Turkey).