On September 13 2022, Legislative Decrees on medical devices (137/2022) and in vitro diagnostics (138/2022) were published in Italy’s Official Gazette. These measures harmonize Italian law with the new EU Regulations 745/2017 and 746/2017 (“Regulations”) – amending and repealing (with specific timelines) the previous decrees – and introduce a new legislative framework consistent with the new EU regulations.
In particular, with regard to the advertising of Medical Devices, the new decrees reflect the contents of EU Regulation 745/2017 (Article 7) in prohibiting the use of text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety and performance. The user could be misled by:
