From 26 May 2021 the Regulation (EU) 2017/745. The regulation amends the rules governing the medical device system, taking into account the developments of the last twenty years, with the aim of guaranteeing a solid regulatory framework, suitable for maintaining a high level of safety.
National authorities, notified bodies, manufacturers, economic operators, health institutions and the other subjects involved will have to collaborate to improve the medical device system in the renewed regulatory framework provided for by the regulation.
The new regulatory context
Regulation (EU) 2017/745, based on the principles of New Legislative Framework, in continuity with the principles of the New Approach, sets itself the goal of raising the quality and safety standards of the products and at the same time creating a sustainable legislative framework, conducive toinnovation which places the EU as guarantor of global health and the proper functioning of the internal market in the medical devices sector.
The May 26, 2021 is, formally, the date from which the full applicability of Regulation 2017/745 takes effect, however, as envisaged by the same, the non-operation of Eudamed allows the use of transitional solutions by the Member States as regards the registration of devices and operators economic, certification notifications, surveillance and clinical investigations.
Furthermore, a derogation period begins in which some of the devices compliant with the directives will be able to continue to be legitimately placed on the market (legacy devices), at the latest until 26 May 2024.
The Ministry of Health engaged on several fronts
The Ministry of Health, Competent Authority and Responsible Authority for Notified Bodies, is working on several fronts, including:
- Notified Bodies: a significant effort is currently underway to ensure an adequate presence of Italian notified bodies aimed at ensuring the conformity of devices on the market
- Participation in the MDCG working groups and in the task forces dedicated to the drafting of the MDCG guidance
- In the European database of medical devices - Eudamed, developed by the European Commission to implement Regulations (EU) 2017/745 and 2017/746, the "player registration" form is accessible; economic operators can register on a voluntary basis in order to obtain the SRN while having to comply with the obligation to register in the national database of medical devices. The integration of the national and European level registration systems is underway
- Adaptation of the national standard: according to theart. 15 of Law 22 April 2021, n. 53, the act of adaptation of the Italian legislation to the provisions of the regulation for the regulation of aspects of health interest, from clinical investigations to post-marketing surveillance, supervision and surveillance of the market is being prepared.
For more information, consult the page:
Ministry of Health – 25 May 2021
