In the Official Journal of 13 June 2023, the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for devices that are not CE-marked and CE-marked but used outside their intended use and the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for CE-marked devices used within their intended use were published. These decrees are provided for in article 16, paragraphs 2 and 3 of Legislative Decree No. 137/2022 issued to bring national legislation in compliance with the provisions of Regulation (EU) 2017/745 (“MDR“).
In particular, the two decrees, which came into force on 13 July 2023, identify the parties entitled to submit applications and communications related to clinical investigations to the Ministry of Health, clarify how to submit the clinical investigation applications and communications, define how and when to acquire the opinion expressed by the Ethics Committee, and how and when to notify the Ministry of Health of the beginning of investigations.
Finally, it should be noted that the provisions stipulated in the two ministerial decrees are effective until the European Medical Device Database (“Eudamed“) becomes fully operative.