Erik Vollebregt
Erik Vollebregt, Partner at Axon Lawyers, 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 specialised 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
Deploy First, Prove Later? The Rise of Real-World Testing in Healthcare
Medical AI is changing faster than traditional pre-market evidence can keep pace. Could carefully controlled real-world testing help close that gap—without asking patients to bear the risk? From the FDA’s TEMPO and the UK’s AI Airlock to emerging initiatives in China, Singapore and the EU, regulators are testing new approaches. This talk explores what makes these pathways useful, what safeguards they need, and when the evidence is strong enough for wider use. Join the discussion on how to test medical AI in care while protecting patients and building trust.
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