Decreto legislativo del 24/02/1997 n. 46, attuazione della direttiva 93/42/CEE concernente i dispositivi medici Supplemento ordinario n .49/l alla GURI - Serie generale - del 06/03/1997 n. 54

This legislative decree implements an EU directive concerning medical devices. It sets out rules for placing medical devices on the market and ensuring their safety and performance. This affects manufacturers, distributors, and users of medical devices, establishing requirements for conformity assessment, labelling, and post-market surveillance.