Italy has stood out as one of the first European countries to recognize the need to postpone certain deadlines set by the Medical Device Regulation (MDR), thus averting the risk of shortages of essential devices for the European healthcare system. According to Dr. Iachino, Director General of Medical Devices and Pharmaceutical Services at the Ministry of Health, speaking at the recent AboutMedicalDevices conference, the extensions obtained have provided Italian companies with breathing space. However, it is crucial to note that these extensions represent an exception to the original European roadmap, with no further postponements anticipated.
The community regulation, born out of an emergency context, is a real test of maturity for the entire sector, requiring that Italy complies with MDR by acting on multiple fronts to ensure compliance and the continuity of healthcare services.
A Renewed Governance for the Medical Device System
Italy complies with MDR by implementing new governance for its medical device system. Among the main initiatives is the establishment of an operational HTA (Health Technology Assessment) steering committee, which is already delivering concrete results. This body works in synergy with regional authorities and procurement centres to define common procurement strategies, taking into account budgetary resources and medical directives.
Moreover, Italy has adopted measures allowing uncertified devices to remain on the market, a critical choice to ensure the continuity of essential devices for the healthcare system.
Notified Bodies: A European Leadership for Italy
Italy boasts the highest number of active notified bodies in Europe—11 in total. This is a crucial advantage in supporting Italian companies in the certification process and ensuring compliance with MDR requirements.
These bodies play a key role in aiding companies in transitioning to the new system, providing the technical support necessary to effectively address regulatory challenges.
Digital Innovation and Flexibility as Keys to the Future
Another priority for the Italian system is digital integration, with particular attention to the growing role of software in medical devices. This sector, discussed since the 1990s, now requires concrete efforts to define clear conditions for use and application.
Additionally, Italy complies with MDR by working to optimize integration with EUDAMED, the European database for medical devices, to eliminate duplications in information flows and simplify processes for manufacturers. The Ministry’s database, however, will remain temporarily active to ensure the functioning of national regulatory activities.
Addressing the challenges posed by MDR requires a flexible and collaborative system, where authorities, businesses, and institutions work together to support the transition. Only in this way can Italy consolidate its role in the European landscape and face this crucial phase of change with confidence.
Aglatech14 ContenTalkers
Laura Legnani – Marketing Services Manager
