Amendment: Eudamed roll-out and IVD medical device provisions
COMCMT1R-EP1R-C2R-EPCNCADO
Updated 25mo ago
This procedure concerns the gradual introduction of a European database for medical devices (Eudamed). It also addresses obligations for suppliers if they interrupt the supply of certain devices and updates transitional rules for specific in vitro diagnostic devices.
The changes aim to improve the traceability and availability of medical devices. This affects manufacturers, importers, distributors, and ultimately patients and healthcare providers who rely on these essential products.