The Italian National Health Service (Servizio Sanitario Nazionale – SSN) is the public healthcare system in Italy. It provides basic medical care, specialist medical care, hospitalization and treatment as well as discounted medication for its patients. Therefore it comprises all health authorities, facilities and hospitals. Only products which had been registered in the so-called Repertorio are available for the SSN.
Registration in the Repertorio is mandatory for Class IIa, IIb and III medical devices and involves a fee of 100 euros. Even though registration by law is not required for Class I products for manufacturers outside Italy, in order to make the product available for the SSN, it is highly encouraged. Without registration, manufacturers can only market their product to private medical facilities, which is a very limited market.
Registration requirements and specific criteria are defined in Health Ministry decrees (2007), with the goal of enhancing device traceability. Accessing the Repertorio database is a rather complicated and time-consuming process. Naturally, there is a variety of documents to be submitted and product-specific questions to be answered. In addition, most information is only available in Italian and the registering company needs a so-called smart card. This is used, for instance, for a validated electronic signature.
“Banca Dati and Repertorio” registration
- Analogously to European Database (EUDAMED), mandatory registration in the Italian Database (Banca Dati – Repertorio) for all medical-device producers
- Health-authority-required registration for Class IIa, IIb and III medical-devices (registration for Class I products is voluntary for non-Italian manufacturers)
- Products in the Repertorio are available for hospital tenders
In order to register a product in Repertorio successfully and in a timely manner, medical-device manufacturers can turn to us for consultancy and to our Italian partners for further guidance.