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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 EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as 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 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.

Topics

Curing the System amidst Geopolitical Trade Wars: Regulatory Reform for Better Health and Innovation

Developing Health Technology
Regulatory Landscape
5.2.2026 10:20 - 11:20 | Hall 205

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.

AI Act and MDR/IVDR 2026 edition: Alignment therapy

Developing Health Technology
Regulatory Compliance on AI
6.2.2026 09:45 - 10:25 | Hall 205