Medical Devices Update – MDCG 2024-4: Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746, April 2024.
– Studies must follow reporting rules set by Article 76 of Regulation (EU) 2017/746;
– Sponsors must report serious adverse events, device deficiencies that could have caused harm, and any new findings related to these;
– Reports go to all involved countries through a specific electronic system (Eudamed);
– There are different reporting requirements for studies on already marketed devices;
– This guidance document provides alternative reporting procedures until the Eudamed system is fully functional.
Read the full document here: https://lnkd.in/dkxxX5Pf
Know more about how to conduct safety reporting in performance studies of IVDs at Medical Devices Regulatory — support unit: https://lnkd.in/dt4tQYNy