From assessment to access: Navigating the EU's new HTA framework

Medicine without diagnostics is blind: closing the global testing gap by MedTech Europe

Sustainability in practice: Jenny Hughes on balancing environmental ambition and patients' access to care by MedTech Europe

In early October 2026, the European Commission adopted its first decision to select two medical devices for joint clinical assessment under the EU Health Technology Assessment (#HTA). What does this mean for medtech innovators? Tune into the latest episode of MedTech ON AIR, recorded live from our booth at The MedTech Forum 2026, where Frédérique Debroucker, Senior Director, EHPR at Medtronic, unpacks how the new HTA framework is set to shape the path from innovation to patient access. The key takeaway: don't wait to prepare. Review your pipeline, anticipate future evidence requirements, and make full use of the tools available under the new framework.

How can Europe ensure that groundbreaking health innovations actually reach patients? At the MedTech Forum 2026, we spoke with Niklas Blomberg, Executive Director of the Innovative Health Initiative (IHI), about the critical challenge of bridging the gap between innovation and patient uptake. We explored the role of public-private partnerships in accelerating medtech innovation, the importance of real-world evidence and health data, the opportunities and challenges presented by AI, and the need to move from policy discussions to practical implementation. The conversation also highlighted sustainability, competitiveness, and collaboration as essential drivers of Europe's future health innovation ecosystem. Learn more about IHI and its health innovation projects: https://www.ihi.europa.eu/

Between sessions at the MedTech Forum 2026, we sat down with Flora Giorgio, Head of Unit D3Medical Devices at the European Commission's DG SANTE. In this conversation, we unpack some of the most consequential files in medtech policy right now: from the revision of the Medical Devices Regulation and the In Vitro Diagnostics Regulation, to EUDAMED implementation and the European Commission’s breakthrough pilot.

From our booth at the MedTech Forum 2026, we sat down with Prof. Marc Peeters, Professor of Oncology at the University of Antwerp and board member of AZ Maria Middelares and Ziekenhuis Geel. We discussed today’s challenges and opportunities in medtech, and AI emerged as a clear leitmotif throughout the conversation. Timely, as discussions on the interplay between the AI Act and the MDR/IVDR revision continue to unfold.

Health drives our lives, from our personal well-being to the health of our planet and economy. On the road to UN Climate Change Conference COP30 in Belém (Brazil), taking place from 10-21 November 2025, we shine a critical spotlight on harnessing medical technology innovation for healthcare decarbonisation.   In this episode of MedTech ON AIR, we are joined by Sigrid Linher, MedTech Europe’s Director for Sustainability and Environment, to discuss the recent MedTech Europe study report commissioned to Boston Consulting Group on “Decarbonising Healthcare: How a Competitive MedTech Industry Can Contribute”.   The episode looks into what inspired MedTech Europe to launch this milestone project, highlighting the key findings from the study. More importantly, it explains why collaboration turns out to be the game-changer for building more sustainable and resilient healthcare systems.   Listen in as we discuss where MedTech Europe heads from here and why staying the course is essential to fulfilling MedTech Europe’s core mission to make innovative medical technology available to more people, while helping healthcare systems move towards a more sustainable path.

Europe’s regulatory system for medical technologies is at a turning point. The European Commission has announced its intention to revise the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 and Medical Devices Regulation (MDR) 2017/745, a process that will shape the future of Europe’s innovation and patient access to safe and effective medical technologies. In the latest episode of MedTech ON AIR, we sat down with Petra Zoellner, MedTech Europe’s Director for Regulatory Affairs, to discuss what’s at stake for patients, innovators and health systems if Europe doesn’t get this reform right. From tackling certification bottlenecks to enabling dedicated pathways for special device types which meet unmet patient needs and breakthrough innovations, this episode explores short- and long-term actions needed to restore trust and predictability in an efficient, innovation-friendly and well-governed regulatory system. Listen in as we discuss with Petra what needs to happen to secure a regulatory system that keeps pace with innovation, safeguards the safety and performance of medical technologies, and strengthens Europe’s global competitiveness.

Cybersecurity has become one of the defining priorities for a digitally advanced healthcare system. With hospitals and healthcare providers increasingly reliant on connected technologies, ensuring resilience against cyber threats is more critical than ever.​ In the latest episode of MedTech ON AIR, we sat down with Benjamin Meany, MedTech Europe Senior Manager for Digital, Software and AI Regulation, to discuss how the medical technology sector is addressing these challenges. ​ From ransomware attacks that disrupt hospital services to the theft of sensitive patient data, cyber threats pose real risks to patients, healthcare professionals, and health systems across Europe. In this episode, we explore the growing impact of cybersecurity incidents on European healthcare and how they are reshaping the way hospitals, professionals, and patients experience care.​ Listen in as we discuss with Benjamin what needs to happen to better protect healthcare infrastructures and reinforce the digital resilience of the European health ecosystem. Learn more about cybersecurity: https://www.medtecheurope.org/digital-health/cybersecurity/ ​

Special episodes of MedTech ON AIR, live from the MedTech Forum 2025, episode 2 This is part 2, of a two-part special edition of MedTech ON AIR, which was recorded live at the MedTech Forum 2025 in Lisbon. The MedTech Forum is the largest gathering of medical technology industry in Europe. In the second part of this special series, we continue to unpack the key takeaways from Europe’s leading health and medical technology industry conference. Our guests reflect on the Forum’s most compelling discussions: from patient engagement and women’s health, to the real-world implementation of sustainability, and the integration of diagnostics in clinical pathways. We explore how the MedTech Forum is helping our industry align on regulatory priorities, and what messages our guests want to convey to European policymakers. Part two continues the story of the MedTech Forum as a moment of alignment, ambition, and direction for the medical technologies sector. *** Listen to Episode 1 here: https://bit.ly/444EDUf Learn more about the MedTech Forum: https://www.themedtechforum.eu/