Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall adhere to Article 76(2) of the IVDR. Sponsors shall promptly report to all Member States any serious adverse events (SAE) with a causal relationship to the device, any device deficiencies that might have led to SAEs, and any new findings related to these events. For post-market performance follow-up (PMPF) studies, the vigilance provisions of IVDR Articles 82 to 85 apply. This document is relevant for PMPF studies as it outlines the reporting procedures for SAEs.
Due to the unavailability and incomplete functionality of the Eudamed, this guidance provides alternative safety reporting procedures. It also defines SAE reporting modalities and includes a summary tabulation reporting format.
For further details, please consult the reference provided.