It was published on Decree of 29 December 2023 of the Minister of Health, which defines criteria and methods for the payment of annual fees, for the monitoring and management of Medical Devices Governance Fund.
The Fund for the governance of medical devices, established by article 28 of the legislative decree of 5 August 2022, n. 137, containing the implementing provisions of Regulation (EU) 2017/745, is fed by an annual quota equal to 0.75% of turnovernet of value added tax, deriving from the sale to the National Health Service of medical devices and large equipment by of companies that produce or market medical devices (article 15, paragraph 2, letter h), of law 22 April 2021, n. 53).
Article 24 of the legislative decree of 5 August 2022, n. 138, containing the implementing provisions of Regulation (EU) 2017/746, provides that the Fund thus established is also fed in the same way by companies that produce or market in vitro diagnostic medical devices.
The Decree of 29 December 2023, issued by the Minister of Health in concert with the Minister of Economy and Finance, defined, as required by legislative decrees 137/2022 and 138/2022, the criteria and methods for the payment of fees annually, for monitoring and managing the Fund.
The Decree indicates that, without prejudice to the destination constraint for the governance of medical devices, the resources flowing to the Fund will be allocated in particular to:
financing of the activities of the national HTA evaluation program for medical devices market surveillance and surveillance activities, with particular reference to the execution of examinations or tests on medical devices and in vitro diagnostic medical devices management of databases activities related to device tracking doctors clinical investigations sector activities related to the National Observatory of medical device prices implementation and management of the IT systems necessary for the governance of medical devices, including information systems to support market supervision and surveillance, as well as medical device registers implantable financing of the activities carried out by the Ministry of Health for the registration of manufacturers, agents and importers in Eudamed definition of guidelines containing rules, technical guides, codifications, classifications and standards necessary to ensure the collection, conservation, consultation and exchange of health data involving the use of medical devices promotion and implementation of health and social-health services based on data on the use of medical devices, in order to ensure data consultation tools of the health data ecosystem (EDS) homogeneous throughout the national territory pursuant to art. 21 of the legislative decree of 27 January 2022, n. 4, converted by law 28 March 2022, n. 25.
As required by article 2 paragraph 4 of the decree, the instructions for making the payment will soon be provided on the Ministry website.