The new in vitro Diagnostic Medical Devices Regulation will come into force in 2022. This new piece of legislation represents a major overhaul of the regulatory system and together with Oliver Bizazza, MedTech Europe Director General for Industrial Policies, we look into the work still needed before the IVDR comes into place on 26 May 2022.

The new IVD Regulation: why more time is needed to achieve success

MedTech Europe's Director for International Affairs, Jesus Rueda Rodriguez, talks about the new and existing healthcare practices in the light of the COVID-19 pandemic.

How COVID-19 is shaping the future of healthcare delivery

Welcome to our new episode of MedTech ON AIR where Michael Strübin, MedTech Europe's Director Digital Health, talks about the benefits of health data for research and innovation in health technologies and how the European Health Data Space could provide what is needed to achieve the digital transformation of healthcare.

The European Health Data Space and the potential of health data

Serge Bernasconi, CEO of MedTech Europe, joined MedTech ON AIR to reflect on 2021 and give his insights on the medical technology sector for the year ahead, and priorities for the European medical technology trade association.

Looking forward to 2022 with MedTech Europe CEO Serge Bernasconi

Patrick Boisseau, Director General Industry Strategic Initiatives at MedTech Europe, explains what is the Innovative Health Initiative, the world largest public-private partnership in life sciences, launched together by four European trade associations, including MedTech Europe.

The Innovative Health Initiative: the future of Research and Innovation in healthcare in Europe

•	Jean-Luc Lemercier, Chair of the Cardiovascular Sector Group at MedTech Europe, talks about the EU NCD initiative and the importance of cardiovascular health.

EU NCD Initiative Roadmap: an first step towards improving the cardiovascular health of EU citizens

Tanja Valentin, Executive Committee member of MedTech Europe, discusses the challenge of diabetes in Europe, the role that digital solutions play in effective management, and what’s still needed to move toward a more digitally enabled future of diabetes care.

Working toward a digitally enabled future for diabetes care in Europe

In October 2022, MedTech Europe ran its latest survey to gather data from IVD manufacturers on the state of the IVDR regulatory infrastructure. The survey represents an estimated 75% market revenue coverage, and the full report and its annex with visuals of the results may be read here: https://bit.ly/3xWp5Cj

A deep analysis of the IVD Regulation

Join us on a special episode of our podcast as we commemorate six years since the adoption of the Medical Devices Regulation with a conversation featuring Merlin Rietschel, Senior Manager Medical Devices at MedTech Europe.

In this insightful episode, we delve into the realm of Medical Devices Regulation and explore its impact on the industry over the past six years. Merlin Rietschel shares his extensive knowledge and sheds light on the challenges, advancements, and key milestones that have shaped the regulatory landscape.

To discover more, visit www.medtecheurope.org/new-medical-technology-regulations/

Six years in: An overview on the Medical Devices Regulation

In this episode, we delve into the fascinating world of artificial intelligence (AI) and its potential in healthcare and medical technology. AI holds the potential to support humans in their daily lives, take care of routine tasks, and advance human knowledge. It has the ability to improve patient outcomes and healthcare systems and assist healthcare professionals in their tasks as it can be present throughout the patient journey.

We engage the discussion with Alexander Olbrechts, Director Digital Health at MedTech Europe, and Edward O'Neill, Director COVID Certification Service and Consultant Medical Adviser Department of Health Northern Ireland.

The value of Artificial Intelligence for the medical technology sector

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]

Deep dive into the MedTech Europe Manifesto & the upcoming EU Elections with CEO Oliver Bisazza

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

The Lifeblood of Europe’s Medical Technology Sector: Collaborative R&I, Mark Lloyd Davies

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

The future of the Regulatory System: are we ready? with Petra Zoellner

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

A Vision for a sustainable healthcare sector, with guest Sigrid Linher

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.

What is in store for the future of the medical technology sector? With guest Stuart Silk

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/

Exploring the Impact of IVDR and MDR -2024 Survey Findings

Special episodes of MedTech ON AIR, live from the MedTech Forum 2025, episode 1This 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.

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

Insights from The MedTech Forum 2025 - Part 1

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/


Insights from The MedTech Forum 2025 - Part 2

Welcome to MedTech ON AIR, the new podcast by MedTech Europe, the European trade association for the medical technology industry. 

Together with experts in the field, we will explore the world of medical technology, touching on the most pressing issues that are affecting the industry, healthcare systems, and society. 

Tune in from January 2020 and join us for the start of our journey.

MedTech ON AIR - Teaser

The three-year transition period for the new Medical Device Regulation will end on 26 May 2020, and the new In Vitro Diagnostic Regulation will come into force in 2022. These new pieces of legislation bring changes to one of the pillars of the medical technology sector: the CE marking process. In this episode, we speak to Oliver Bisazza about what this process is, how it changes and what the medtech industry has to say about it.

The changing EU regulatory landscape: CE Marking for Medical Technology

The coronavirus outbreak has placed focus on the mechanisms and technologies that help us prevent and fight these crises. Medical technology plays an important role in the combat against COVID19, supporting patients, systems and healthcare workers in different ways. In this episode, we talk to Jesus Rueda Rodriguez and we take a closer look at the what medical technology can do and how it is contributing to the international response against coronavirus.

Diagnosis, protection, treatment: the medtech response to coronavirus (13 Feb 2020)

MedTech Europe International Affairs Director, Jesus Rueda Rodriguez, helps us shed some light on the so-called ‘Phase 2’ or deconfinement and how medical technology plays a role to inform and shape European and national strategies. Also in this episode: how will healthcare systems adapt to the ‘new normal’? How we can make sure that people affected by chronic conditions or other illnesses receive the best possible care?

COVID-19: Medical technology and the road to deconfinement

Together with MedTech Europe's Director for Research and Innovation, Patrick Boisseau, we look at the European research and innovation landscape during a year of both crisis and transition. Will the lessons learned from COVID-19 be incorporated in the new programmes? What are the coming changes for medical technology in the research space? Listen to episode 4 of MedTech ON AIR to find the answers to these and other questions.

Change is on the Horizon: medtech in the research and innovation space

As we approach the end of the year, Europe is faced with a second wave of coronavirus, with many states going back into lockdown. The situation seems to reflect what happened in March when COVID-19 first appeared in Europe, and governments took drastic measures to keep their healthcare systems running. However, some things have changed since the first wave. Among them, the readiness of healthcare systems and industry. In this episode of MedTech ON AIR, we explore this and more with MedTech Europe's Director for International Affairs, Jesus Rueda Rodriguez.

COVID-19 second wave: what has changed

A podcast by MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health.

MedTech ON AIR

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