Theme Safety reporting in performance studies 
Target Audience Sponsor of performance studies 
Products concerned IVD
Documents mentioned

IVDR (EU) 2017/746 : article 76 

In a context where the Eudamed electronic system for performance studies is not available, this guide aims to help sponsors report adverse events occurring during performance studies, including post-market performance follow-up studies (PMPF). 

This document sets out the procedures for reporting adverse events and includes in appendix a model report in the form of a summary table.