Clinical trials of Medical Devices – Updates Regarding Ethics Committees and its composition by Italian Ministry of Health

There have been so many changes in the clinical trial framework in Italy including four new decrees concerning clinical trials on medical devices and medicines for human use.

The Ministry released a Circular on February 28, 2023, outlining the ways in which the decrees should be applied and the effects of the new rule. Particularly, the effects of the rules established by the Decree of the Minister of Health of January 30, 2023, on the definition of the criteria for the composition and operation of the territorial ethics committees, and by the Decree of the Minister of Health of January 26, 2023, on the identification of 40 territorial ethics committees.