Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices
COMCMT1R-EP1R-C2R-EPCNCADO
Updated 22mo 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.
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