| 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.