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

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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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

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 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

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

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/

The changing EU regulatory landscape: CE Marking for Medical Technology

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