Italy enacted legislation to adapt the national framework governing medical devices and in vitro-diagnostic medical devices to the MDR and IVDR.
The new Legislative Decrees 137 and 138 were published in the Italian Official Journal on September 13, and will apply from September 28, 2022, save for specific transitional measures. Italian provisions regulate national aspects on medical devices and in vitro-diagnostic medical devices, ranging from language requirements, the registration of distributors in the national database, derogation from the applicable conformity assessment procedures, and penalties.
Furthermore, new provisions confirm (see our previous article here) that companies must obtain prior authorization before advertising to the general public non-prescription devices and devices that patients can use without the assistance of a physician. Contrarily, advertising to HCPs does not require authorization and is subject to further guidelines by the Ministry of Health.
The Ministry of Health must adopt subsequent decrees to regulate procedures in specific areas, including registering manufacturers of custom-made devices in the national database, reporting incidents, and treating named patients. Further provisions will also define aspects such as the storage of the unique device identification system by HCOs and HCPs, clinical investigation, the national Health Technology Assessment program, and the national fund for medical devices.