On 7 February 2023, the four ministerial decrees envisaged by article 2 of the law of 11 January 2018, n. 3, concerning clinical trials on medical devices and medicines for human use.
On February 28, 2023, the Ministry issued a Circular which provides indications regarding the methods of application of the decrees and the implications of the new regulation.
In particular, the effects of the provisions introduced by the Decree of the Minister of Health of 30 January 2023 on the definition of criteria for the composition and functioning of territorial ethics committeesand by the Decree of the Minister of Health of 26 January 2023, on theidentification of 40 territorial ethics committees.
The innovations brought about by these two decrees therefore require updating the indications that had been provided with the Circular of 25 May 2021, relating to the first application of EU Regulation 2017/745 in the sector of clinical investigations relating to medical devices.
Clarifications are also needed on the similarities and differences between clinical investigations of medical devices and clinical trials of medicinal products with regard to tariff system and the transitory phase which elapses between the publication of the decrees and the full operation of the 40 recently identified territorial ethics committees.
Criteria for the composition and functioning of the local ethics committees
Il Decree of the Minister of Health January 30, 2023 establishes that, starting from 8 February 2023, the date of its entry into force, the territorial ethics committees (also referred to as “CET”) and the national ethics committees are exclusively competent for the evaluation of clinical investigations on medical devices (also referred to as «CEN»).
Identification of the local ethics committees
The second ministerial decree, Decree of the Minister of Health January 26, 2023identifies the territorial ethics committees exclusively responsible for the evaluation of clinical investigations on medical devices.
Furthermore, the Decree of the Minister of Health of 26 January 2023, on the identification of forty territorial ethics committees, and the Decree of the Minister of Health January 30, 2023on the determination of the single tariff for clinical trials, repeal theart.7 of the legislative decree 24 June 2003, n. 211.
Laws
The news of February 8, 2023: