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.

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Listen to Episode 1 here: https://bit.ly/444EDUf

Learn more about the MedTech Forum: https://www.themedtechforum.eu/

Special episodes of MedTech ON AIR, live from the MedTech Forum 2025, episode 1This two-part special edition of MedTech ON AIR was recorded live at the MedTech Forum 2025 in Lisbon — the largest gathering of the medical technology industry in Europe.

In these episodes, we explore the MedTech Forum’s role as a pivotal gathering, where the themes and conversations will shape the direction of the medical technology industry for years to come.

Listen in as our guests share their reflections on the MedTech Forum, how Europe can strengthen its position as a global hub for innovation, the growing focus on sustainability, and the role of early diagnosis and prevention in transforming patient care. Our guests also share insights into regulatory challenges, the digital health ecosystem, cybersecurity, the evolving policy landscape, and much more.

Together, this two-part series offers a multi-angled view of where our sector stands today — and where it is heading.

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Learn more about the MedTech Forum: https://www.themedtechforum.eu/

Welcome to the 6th Season of the MedTech ON AIR podcast. ​

This 2025 season kicks off with an episode dedicated to the 2024 Regulatory Survey findings​

The 2024 Regulatory Survey revealed key challenges that manufacturers face under the In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) – from conformity assessment timelines, to the costs of compliance, to the impact on research and innovation, the report highlights important trends ​

Listen in as Petra Zoellner, Director IVDR and MDR, dive deeper into the findings, and discusses what they mean for manufacturers still navigating the transition, and what policymakers and all stakeholders can do to improve regulatory predictability. ​

Find the regulatory survey here: https://www.medtecheurope.org/resource-library/medtech-europe-2024-regulatory-survey-key-findings-and-insights/

Are you curious about what is in store for the for the future of the medical technology sector?

In the season finale of the MedTech ON AIR podcast, we welcomed newly appointed Chairman of MedTech Europe’s Board of Directors, Stuart Silk.

Listen in as Stuart shares his reflections on the EU political cycle for 2024-2029, our industry’s key role in driving the attractiveness of the European region, and what the outlook is for the medical technology sector in the years to come.

Ready to learn more about what sustainability means in the healthcare sector?

The latest episode of MedTech ONAIR is now live. In this episode, we welcome MedTech Europe Director of Sustainability & Environment, Sigrid Linher, to discuss MedTech Europe’s vision for achieving environmentally sustainable, equitable and resilient healthcare systems.

Listen in as we discuss with Sigrid what needs to happen to ensure that the medical technology sector and healthcare systems, more broadly, continue to fully embrace sustainability.

Have you read MedTech Europe’s reflection paper on building resilient and sustainable healthcare systems?

If not, check it out here: https://bit.ly/3V8ttL4

Ready to learn more about the future of the medical technology regulatory system?

The latest episode of MedTech ONAIR is now live. In this episode, we welcome MedTech Europe Director of Regulatory Affairs, Petra Zoellner, to discuss our Vision for the future of the EU’s regulatory system for the Medical Technology Sector.

Listen in as we discuss with Petra why different measures are needed to ensure that the EU’s regulatory system facilitates innovation, better serves patients’ needs and strengthens the whole healthcare ecosystem.

Notes and links:

Have you read MedTech Europe position paper on the Future of Europe’s Medical Technology Regulations? Check it out here: https://bit.ly/3TGo5N0

Access the survey report referenced in the podcast "Current assessment of the German medical device manufacturers on the effects of the EU Medical Device Regulation (MDR)" here: https://bit.ly/3PDIAJa

How do Europe’s unique R&I environment and opportunities provide fertile ground for our sector’s life changing innovations?

In the second episode of MedTech ON AIR, we welcome Johnson & Johnson’s Global Head of Strategic Partnerships and Resource Group (SPRG), Mark Lloyd Davies.

Listen in as Mark as shares his insights from his longstanding experience working in collaborative research and innovation in Europe, and what makes the EU environment unique. We delve into the potential of public private partnerships, practical advice on participating in the Innovative Health Initiative, and reflections on a new multistakeholder project.

Curious to learn more about the red thread driving the medical technology sector? Learn more in the MedTech Europe Manifesto: https://bit.ly/49zo9W2

Ready to elevate your understanding on the future of healthcare and the medical technologies sector?

The new season of MedTech ON AIR is live for the 2024. In this episode, we welcome MedTech Europe CEO Oliver Bisazza to discuss our Manifesto, and the European Elections.

Listen-in to this first discussion with Oliver, exploring important topics like patient-centricity, digital transformation, and sustainability shaping the medical technologies sector today and beyond.

We’re kicking-off a series of episodes on the future opportunities of the upcoming elections, healthcare in Europe, innovation opportunities and outlook for the medical technology sector.

Have you read the MedTech Europe Manifesto? Check it out here: https://bit.ly/49zo9W2

Curious about how the MedTech Europe Manifesto positions patient centricity? You can learn more in our latest blog post Empowering Patients Will Boost the Quality of Healthcare: https://bit.ly/3UtIKpG]