Operating within the European Union, Italian medical device manufacturers and importers must adhere to stringent regulatory frameworks that ensure patient safety and product efficacy.

Compliance and CE Marking The primary regulatory benchmark is the EU Medical Device Regulation (MDR). All devices marketed in Italy must bear the CE mark, certifying that they meet essential health and safety requirements. The Ministry of Health, specifically the Directorate General of Medical Devices and Pharmaceutical Services, acts as the competent authority responsible for market surveillance and the registration of new products.

The National Directory (Repertorio) A unique requirement in Italy is the mandatory registration of medical devices in the National Health System directory, known as the Repertorio. Before a product can be sold to public hospitals or private clinics, it must be assigned a unique identification number in this database. This system allows for transparency in procurement and ensures that only registered, compliant devices are utilized within the public healthcare network.

Language and Documentation To ensure clear communication and safety, all instructions for use, labeling, and packaging must be translated into Italian. Manufacturers from outside the European Union must appoint an Authorized Representative (AR) based within the EU to handle these registrations and serve as a point of contact for Italian health authorities