MDG – MedGenerAction 2025: The New Frontiers of Medical Devices

Bologna, October 1, 2025 – Hotel NH Bologna de la Gare and live streaming

Innovation in medical devices is advancing at an unprecedented pace. However, without clear and consistently applied regulations, market access may slow down, and patients might not benefit promptly from new technologies. Regulatory compliance thus becomes a strategic factor, especially for manufacturers: it is what allows safety, efficacy, and genuine innovation to coexist.

In this context, MDG – MedGenerAction, the international summit organized by Complife Group, takes center stage. The event will take place on October 1, 2025, in Bologna (Hotel NH Bologna de la Gare) and online via live streaming. The summit will offer a unique opportunity to engage with experts from competent authorities, notified bodies, and the medical industry.

Key Topics of Discussion
The summit addresses the complexity of regulatory management, exploring current and future challenges in an ever-evolving sector. Main topics include:

  • The extension of the MDR Regulation (EU 2023/607) and its implications for manufacturers and notified bodies, with a contribution from Alessandra Basilisco (Ministry of Health);
  • European governance of medical technologies, featuring insights from Jana Russo (MedTech Europe) and an in-depth look at the document "Future Governance of Medical Technologies in Europe."

Technical Roundtables and Sector Focus
In the afternoon, 9 thematic Technical Roundtables will allow participants to explore crucial aspects for the industry:

  • Cybersecurity and the impact of the NIS2 Directive
  • Rules for medical software
  • New challenges for substance-based devices
  • UDI-related criticalities
  • Advanced design of electromedical devices
  • Biocompatibility and risk assessment
  • Packaging validation
  • IVDR challenges

All sessions will be simultaneously translated into English, encouraging international participation.

Statements
"With MDG – MedGenerAction, we have created a concrete space for dialogue among those who develop, regulate, and use medical devices. Technological evolution is extremely rapid: it is essential to build a professional dialogue that makes the system more effective and patient-centered," said Silvia Tamarri, General Manager of Thema (Complife Group).

Practical Information

  • Date: October 1, 2025
  • Venue: Bologna, Hotel NH Bologna de la Gare and live streaming
  • Participation: free upon registration at www.medgeneraction.it
  • Languages: Italian and English