The scientific program at Labquality Days includes a program track on Developing Health Tech. Join us as we kick off the Health Tech track with a timely panel on Europe’s evolving medtech regulations and what they mean in today’s turbulent geopolitical climate!
In an increasingly interconnected world, the global medtech market is navigating a complex web of geopolitical tensions, regulatory reforms, and shifting trade dynamics. This panel aims to provide clarity on the evolving landscape, focusing on the intersection of regulation, innovation, and international trade.
With the European Union restructuring its regulatory frameworks, ongoing concerns over overregulation, and the shifting tariffs and policies between the U.S. and China, the medtech industry faces both significant challenges and opportunities. As regulatory bodies work to balance patient safety, market access, and innovation, industry leaders must adapt to remain competitive on a global scale. This session will explore the key forces shaping the medtech market today, including:
- Review of the European Commission's proposed legal text in view of addressing innovation and patient health
- The competitiveness of the EU medtech industry amidst global regulatory restructuring
- The impact of the legislative proposal in view of shifting geopolitics, global regulatory restructuring, medical supply chains and partnerships
- The evolving role of big tech in reshaping the healthcare landscape, from product development to patient care
Through expert insights, the discussion will highlight strategic approaches to navigating these turbulent times, with a focus on how regulatory reform can foster an environment of growth and innovation. Attendees will leave with a clearer understanding of the global medtech landscape, practical takeaways on navigating regulatory and geopolitical challenges, and a vision for the future of healthcare innovation on the world stage.
Expert panelists
Koen Cobbaert
Regulatory Science & Policy Expert
Philips
Belgium
Koen Cobbaert is a Regulatory Science and Policy Expert at Philips, focusing on how tech law and supporting standards apply to digital health products. Since 2010, he has led the software focus group at the trade association COCIR and represents the membership in various MDCG, IMDRF, and AI Office fora that focus on software and AI. He participated in numerous European Commission workshops leading up to the AI Act, and in 2023, he moderated an AI Act session with notified bodies in the European Parliament.
Nelli Karhu
Senior Advisor
Terveysteknologia ry HealthTech Finland
Nelli Karhu is a senior advisor for HealthTech Finland. She has extensive experience in MD and IVD regulatory issues on both the national and EU levels. Before joining HealthTech Finland in 2025, Nelli worked as a Senior inspector and Section Head in the Finnish competent authority for medical devices, Fimea. Now, as a senior advisor for HealthTech Finland, Nelli supports Finnish healthtech companies with regulatory issues, as well as working for a better regulatory environment for the European healthtech sector. Nelli is a biochemist by training, with a PhD in bacteriophage structure and evolution. In addition to medical device regulatory issues, viruses, and especially bacteriophages, are still close to her heart.
Erik Vollebregt
Attorney-at-law, partner
Axon Lawyers
The Netherlands
Erik specialises in EU and national legal and regulatory issues relating to medical devices, including AI, batteries, REACH and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as an intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU level via membership of specialized committees at branch associations and the European Commission. Erik occasionally advises EU member states about legal and regulatory aspects of MDR and IVDR implementation.
Share this article
