MDCG – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation
(EU) 2017/746
Medical Device Coordination Group (MDCG) released a document on 15 April 2024 as per Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. This document defines SAE reporting modalities and includes a …