A little more than a month from the date of full applicability of the Regulation on Medical Devices 2017/745, the transposition of the European directives and the implementation of other European Union acts, in Italy pass from Parliament to the Government, as sanctioned by the Delegated Law n. 53 of 22 April 2021.
The art. 15 of this Delegation Law Law establishes the principles and criteria for the adaptation adaptation of the national legislation to MDR 2017/745. We remind you that the Regulation on Medical Devices is actually already in force from 26/05/2017, but that its full applicability will take place on 26/05/2021, after the transition period initially envisaged of 3 years and then extended for a further 12 months. due to the Covid-19 pandemic.
The Government must adopt, , within 12 months from the date of entry into force of the Delegation Law, one or more legislative decrees for the redefinition of the following areas:
Vigilance and Post-Market Surveillance. It is necessary to implement coordination and reorganization of the national provisions in force with those of the Regulation, with particular focus on the methods and procedures of vigilance , market surveillance and of safety control of medical devices, fundamental adjustments if we consider the proactivity of these procedures dictated by the MDR .
Communication. The Government will have to establish the contents, the timing and the modalities of recording the informations that the manufacturers, the distributors users are required to communicate to Ministry of Health.
Management. It will be necessary to reorganize and coordinate the activities of the public bodies responsible for the governance of medical devices, including the revision of the mechanism for defining expenditure ceilings.
Sanctioning system. The sanctioning system will have to be redefined on the basis of the new and wider obligations for manufacturers imposed by the MDR. Administrative penalties, , which must be “effective, dissuasive and proportionate to the seriousness of the violations of the provisions of Regulation (EU) 2017/745 and Regulation (EU) 2017/746”, will bereduced by one third in the event of violation by micro-enterprises.
Unique Device Identifier – UDI. The government is entrusted with identifying the methods of traceability of the DM through the reordering and connection of databases in accordance with the Unique Device Identifier – UDI, so as to safeguard the most complete information level.
Health Technology Assessment – HTA. Subject to agreement between the State, the Regions and the Autonomous Provinces, it will be necessary to strengthen the functions of HTA and adapt the activities of the Observatory on the purchase prices of devices di in order to make the purchasing procedures more efficient.
GDPR. The activities envisaged by the MDR, such as clinical evaluation and post-marketing surveillance, with an attached monitoring system, measurement of results and data analysis, involve extensive processing of personal data and must therefore be compliant to the GDPR. Particular attention should be paid by the adaptation decree on the passage of data collected by health professionals and hospitals to manufacturers.
Financing system. There will also be a system of government financing of medical devices through the payment by companies that produce or market medical devices of aquote not exceeding 0.75% of the turnover, net of VAT,deriving from the sale of medical devices and of delle large equipment to the national Health Service.