2024-04

The European Commission published MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 .

This guidance outlines the procedures for safety reporting in performance studies in the absence of the Eudamed module or when Eudamed is not yet fully functional (see also sections 5.1 and 5.2 in this guidance).

The document also defines SAE reporting modalities and includes a summary tabulation reporting format.

The document can be downloaded in our library

Source: European Commission