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 risks being delayed and patients may not benefit from new technologies in a timely manner. Regulatory compliance thus becomes a strategic factor, especially for manufacturers: it is what enables the reconciliation of safety, efficacy, and genuine innovation.

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

Key Topics of Discussion

The summit addresses the complexity of regulatory governance, exploring current and future challenges in a constantly evolving sector. Key topics include:

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

Technical Sessions and Sector Focus

In the afternoon, 9 thematic technical sessions will allow for in-depth exploration of crucial aspects for the industry:

  • cybersecurity and the impact of the NIS2 directive,
  • regulations for medical software,
  • new challenges for substance-based devices,
  • UDI critical issues,
  • advanced design of electromedical devices,
  • biocompatibility and risk assessment,
  • packaging validation,
  • IVDR challenges.

The proceedings will be simultaneously translated into English, facilitating international participation.

Statements

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

Useful Information

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