Italy has recently instituted substantial changes in the national legislation on the supervision of medical devices in order to align our procedures with the European Regulations 2017/475 for medical devices and 2017/476 for in vitro diagnostics. From 16 October 2022, the new rules of the Decree of 21 March 2022 “Establishment of the national network for the surveillance device and the information system to support it” published in the Official Gazette on April 16 2022 will be mandatory.