Bologna (BO), October 1, 2025 – MDG MedGenerAction 2025 is the international summit dedicated to professionals in the medical devices sector, organized by Complife Group, a GBA Group company. The event took place at the NH Bologna de la Gare Hotel and via live streaming, with the participation of over 150 industry professionals.

Roundtables: A Morning of Intense Exchange Among Industry Professionals
The morning sessions saw the participation of experts and representatives of notified bodies, with interventions focused on the new regulatory challenges introduced by EU Regulation 2017/745 (MDR) and the role of technological innovation in ensuring the safety and efficacy of medical devices.
Speaker Alessandra Basilisco, Biomedical Engineer at the Ministry of Health, opened the debate “Governance Today: Managing Complexity in an Ever-Changing Landscape,” presenting the latest data on MDR certificates, submitted practices, those under review, and review times by Notified Bodies.

During her speech, she emphasized that “things are moving in the direction hoped for by everyone, but not as quickly as we would have expected,” highlighting that one of the main critical issues is that “it is still not possible to find the right balance between the manufacturer’s duties and the role of the notified body.” According to Basilisco, the system is already complex, and to avoid further slowdowns, she stressed the need to “reduce burdens for manufacturers and bodies, improve process predictability, and promote digitalization,” as well as encourage international recognition pathways and simplify the regulation “to support innovation with proportionate and facilitated routes.”

The second roundtable, “Shaping Tomorrow: New Frontiers in Medical Technologies Regulation,” began with the intervention of Jana Russo, Medical Devices Manager at MedTech Europe, who presented the position paper “Future Governance of Medical Technologies in Europe,” a joint document from leading European associations aimed at proposing a reform of the regulatory system to make it more efficient, transparent, and patient-oriented.
“Core problems can be solved by somebody who is automatically responsible for devices getting to the market and available to patients,” Russo stated. For this reason, the concept of “captain of the ship” is introduced, a unique and responsible governance structure specific to the medtech sector. The motivations behind this proposal include “the necessity of centralization of responsibilities, strengthening innovation and competitiveness, improving efficiency and predictability, all for the patients’ benefits.”
While requiring coordination and horizontal harmonization in European legislation, Russo reiterated the importance of maintaining notified bodies as a key part of the future system.

Technical Tables: Debates on Current Critical Issues by Device Category
The afternoon session involved sector professionals in technical tables on specific crucial topics and regulatory challenges in the medical devices field. Attendees had the opportunity to choose from the following debates based on personal interests and relevance to their roles:

  • NIS2 & Medical Devices: Ready for the Cybersecurity Revolution?
  • All-in-One Biocompatibility: ISO 10993 Update, Risk Assessment & Real-World Data
  • Smart Design: Building Compliant Medical Software
  • UDI Challenges: From Active Devices to IVD Software – What’s Changing?
  • Packaging Validation: How to Protect Your Product and Your Compliance
  • Substance-Based Devices: A New Frontier in Medical Design
  • Cybersecurity Risk Management: The Secret Weapon of Your Next Submission
  • IVDR Critical Milestones: What You Need to Know Now
  • Electromedical Devices: Design Challenges & Regulatory Impact

MDG – MedGenerAction 2025: The Reference Event in the Medical Devices Sector
MDG – MedGenerAction 2025 confirmed itself as the annual reference event for medical device professionals who wish to stay updated and actively engage with all stakeholders in the sector. Having a clear view of the regulatory landscape facilitates the achievement of the common goal of maintaining product ethics and safety, allowing the progress of this ever-evolving sector.
The debates highlighted the current critical issues of the various parties composing the regulatory macrocosm, promoting research towards a more efficient medical device management system.
Once again, the event enjoyed the support of numerous excellence partners. The Supporting Partner was IRA – Istituto Ricerche Applicate, a leader in scientific research. The Community Partners included Buona, CCA, ChSA Pharma, DICOM Vision, Elcam Medical, Med’s Farmaceutici, Farmigea, Finceramica, Futura Vitasana, LCB, Plastod, Realbit, Smeg Instruments, and Stewart Italia. Finally, Technical Partners included BSI, Bureau Veritas, CQY Certiquality, DNV, IMQ, Kiwa, Rucellai & Raffaelli Law Firm, and TÜV Rheinland/TÜV SÜD.

Further Insights
Watch the video interviews to discover the speakers’ perspectives on the topics discussed:

About Us
Complife Group is an international group offering consulting and testing services for the Health & Care sector (cosmetics, supplements, medical devices, pharmaceuticals). For more information: www.complifegroup.com
Thema, founded in Imola in 2007, provides consultancy and training in Quality & Regulatory Affairs for the medical sector. Since 2021, it has been part of the Complife Group. Info: www.thema-med.com