Italy: The MoH decree establishing the Fund for Medical Device Governance Auto Draft

Rome: With Decree of 29 December 2023, published on 9 February, the Ministry of Health identified the criteria and procedures for the payment of the annual fees for the monitoring and management of the Fund for the Governance of Medical Devices referred to in Article 28 of Legislative Decree No. 137/2022 (“Fund“).

The Fund has been established with the purpose of financing, among other things, the activities of the national plan for the Health Technology Assessment of medical devices managed by the National Agency for Regional Health Services and those related to the governance of medical devices carried out by Regions and Autonomous Provinces.

The Fund will be financed through the payment by companies manufacturing or marketing medical devices of an annual fee equal to 0.75% of the turnover, net of VAT, resulting from the sale of medical devices and large equipment to the NHS. The financial burden arising from this measure, which is additional to the payback on medical devices, will be borne by medical device companies. Since the annual fee is calculated on the basis of the turnover, rather than on profits, several operators are considering the possibility of challenging the aforementioned Ministerial Decree before the administrative judge within sixty days from the date of its publication.