This year, the 10th session of the 64th AFI Symposium, dedicated to medical devices, promises to mark a crucial moment of discussion. The chosen theme — “Innovation and the Use of New Technologies for Substance-based Medical Devices in the Context of the MDR” — reflects the main challenge facing the sector: combining technological progress with increasingly stringent safety and quality requirements.
The MDR regulatory context has pushed companies to develop significant expertise in managing the demands of Notified Bodies: from the collection and presentation of clinical data to process evaluation, as well as the toxicological and clinical assessment of substance-based medical devices. The session on June 12 will therefore be an opportunity to take stock of the progress made and the challenges still ahead.
At the same time, innovative devices designed from the outset with MDR compliance in mind have entered a more advanced certification phase. Some of these devices have already achieved MDR certification, a clear sign that technological innovation and high-quality clinical data are now essential elements for success in the European market.
Emerging technologies, such as artificial intelligence, promise to radically redefine the sector’s operations. However, as noted by Mauro Rainoni in the video introducing the session, they require a careful and responsible approach:
“The June 12 session will be an important test. Companies face a delicate balance: leveraging the potential of AI and new technologies, but with risk management that meets the expectations of both regulators and patients. It is crucial that innovation strategies are accompanied by rigorous compliance with certification procedures and clinical evidence.”
The session will be moderated by Dr. Marlette and Dr. Leone, two prominent figures in Italian medical device regulation. Together with them, engineer Alessandra Basilisco from the Ministry of Health will update participants on the latest legislative developments and potential future regulatory changes—essential to navigating an ever-evolving landscape.
Also highly anticipated is the speech by Guido Beccagutti, the new Director General of Medical Devices at Confindustria. Beccagutti will confirm the intention to strengthen cooperation between AFI and Confindustria, with the goal of boosting the competitiveness of Italian companies and promoting responsible and sustainable innovation.
But what will be discussed?
The expert panel will address the collection and presentation of clinical data for substance-based medical devices—still the cornerstone of MDR certification. They will discuss combination products, a growing area that requires an integrated regulatory approach and constant dialogue among all stakeholders. The session will explore the certification of innovative devices developed as “MDR-ready”, providing insights into best practices and remaining obstacles, and will delve into the topic of artificial intelligence—a frontier theme that, while already well established in diagnostics, still presents uncertainties and gray areas in substance-based medical devices.
As Rainoni emphasized in his comment, “The use of AI in these devices cannot be seen as a mere shortcut. On the contrary, it is a tool that must be managed responsibly, because every new algorithm or predictive system has direct implications for the safety and effectiveness of products.”
In this scenario, the role of Notified Bodies is once again confirmed as central. Their mission is to ensure the standardization of assessments and a consistent level of quality and safety for all certified devices, safeguarding patients and the healthcare system.
Thus, June 12 will be more than just a technical update: it will be an opportunity to share experiences, to engage in open dialogue, and to identify the most effective strategies for consolidating the competitiveness of Italian industry in an increasingly demanding global market. The AFI Symposium is confirmed as a privileged venue for dialogue and synthesis, where interaction between companies, Notified Bodies, and authorities represents the true engine of innovation.
Looking ahead to the upcoming session, a clear message emerges: sustainability and quality are no longer mere options—they are essential conditions for success. The companies that will be able to integrate new technologies while ensuring compliance with regulations and patient safety will be the ones best positioned to turn today’s challenges into tomorrow’s opportunities.
