On April 23, Law No. 53 of April 22, 2021, “Delegation to the Government for the transposition of European directives and the implementation of other European Union acts,” was published in the Official Gazette (“Delegation Law”).
Article 15 of the Delegation Law provides principles and criteria for the government to use in adapting the national regulatory framework to the provisions of the Medical Devices Regulations (EU Regulations 2017/745 and 2017/746) by issuing one or more legislative decrees within the next 12 months.
According to the principles and criteria established by the Delegation Law, the government will have to:
- adapt to the EU Regulations existing national provisions concerning modalities and procedures for supervision, market surveillance, and safety oversight of medical devices, with express abrogation of any incompatible national provisions;
- establish the contents, timing, and methods for recording information that manufacturers and distributors of medical devices, as well as users, are required to communicate to the Ministry of Health;
- arrange for the reorganization and coordination of activities among the entities responsible for the governance of medical devices, including the reorganization of the mechanism to set public expenditure ceilings for the purpose of application of the payback system with respect to the medical devices sector, according to Law Decree 78/2015;
- establish a sanctioning system through the provision of effective, dissuasive administrative sanctions proportionate to the severity of violation of the provisions of the Medical Devices Regulations (the sanctioning system will also have to provide for a reduction of one-third of the administrative penalty in the event of a breach committed by a micro-enterprise);
- better identify the methods of traceability of medical devices through the reorganization and connection of existing or implementing databases in accordance with the Unique Device Identification System (UDI System) provided for by the EU Regulations;
- make medical device purchasing procedures more efficient by strengthening Health Technology Assessment (HTA) procedures;
- adapt the processing of personal data carried out pursuant to the Medical Devices Regulations to the provisions of Regulation (EU) 2016/679 (or GDRP) and to the current legislation on the protection of personal and sensitive data; and
- introduce the obligation for companies that produce or market medical devices to pay a share of no more than 0.75% of their turnover resulting from sales of medical devices and large equipment, net of value-added tax, to the National Health Service for the purpose of financing the system for governance of medical devices.
Considering the above, it seems that the new legislative provisions to be issued for the main purpose of adapting the existing Italian regulatory framework to the EU Regulations on medical devices might present an opportunity to address certain general issues concerning the governance of medical devices in Italy.
- Elisa Stefanini, Counsel
Thanks to Giulia Conforto for collaborating on this article.
Compliments of Portolano Cavallo – a member of the EACCNY.