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

Round Tables: A morning of intense discussion among industry professionals

The morning sessions saw the participation of experts and representatives from notified bodies, with presentations 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 from the Ministry of Health, opened the “Governance Today: Managing Complexity in an Ever-Changing Landscape” debate, presenting the most up-to-date data on MDR certificates, submitted applications, those under evaluation, and review times by notified bodies.

During her presentation, she emphasized that “things are moving in the direction everyone hoped for, but not as quickly as we would have expected,” highlighting that one of the main critical issues is that “a balance has yet to be found between the manufacturer's duties and the role of the notified body.” According to Basilisco, the system is already complex, and to avoid further delays, she stressed the need to “reduce the burden on manufacturers and bodies, improve process predictability, and encourage digitalization,” as well as promoting international recognition pathways and simplifying the regulation “to support innovation with proportionate and facilitated pathways.”

The second round table, “Shaping Tomorrow: New Frontiers in Medical Technologies Regulation”, began with a presentation by Jana Russo, Medical Devices Manager at MedTech Europe, who illustrated the position paper “Future Governance of Medical Technologies in Europe,” a joint document by the main 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,” stated Russo. For this reason, the concept of “captain of the ship” is introduced—a single, responsible governance structure specific to the medtech sector. The reasons 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 reaffirmed the importance of maintaining notified bodies as a key part of the future system.

Technical Sessions: Discussions on current critical issues specific to device categories

The afternoon session involved the participation of industry professionals in technical sessions on specific crucial topics and regulatory challenges in the medical device sector. Guests had the opportunity to choose from the following discussions 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 benchmark event in the medical device sector

MDG – MedGenerAction 2025 has established itself as the annual benchmark event for medical device professionals who wish to stay updated and actively engage in discussion with all stakeholders in the sector. Having a clear vision of the regulatory landscape facilitates the achievement of the common goal of maintaining product ethics and safety, allowing for the progress of this constantly evolving sector.

The discussions brought to light the current critical issues of the various parts that make up the regulatory macrocosm, promoting research toward a more efficient system for managing medical devices.

Once again this year, the event enjoyed the support of numerous partners of excellence. The Supporting Partner IRA – Istituto Ricerche Applicate, a leader in the scientific research sector. The Community Partners: Buona, CCA, ChSA Pharma, DICOM Vision, Elcam Medical, Med’s Farmaceutici, Farmigea, Finceramica, Futura Vitasana, LCB, Plastod, Realbit, Smeg Instruments, and Stewart Italia. Finally, the Technical Partners, including BSI, Bureau Veritas, CQY Certiquality, DNV, IMQ, Kiwa, Rucellai & Raffaelli Law Firm, and TÜV Rheinland/TÜV SÜD.

Insights

Watch the video interviews to discover the speakers' points of view on the topics discussed:

Who we are

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 was founded in Imola in 2007 and provides consulting 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