MedTech ON AIR - Reforming the regulatory framework for medical technologies
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.
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Cybersecurity in the medical technology system
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/
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Insights from The MedTech Forum 2025 - Part 2
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/
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Insights from The MedTech Forum 2025 - Part 1
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/
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Exploring the Impact of IVDR and MDR -2024 Survey Findings
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/
A podcast by MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health.
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