Europe’s ‘Regulatory Lasagna’: Commission Facing Yet More AI Act Criticism

Is regulating artificial intelligence a good idea? A lawyer questions whether the European Commission’s proposed AI Act is appropriate for medtech, where a growing “regulatory lasagna” could compound notified body capacity issues and SME workload.

MedTech Europe Conference Panel Discussion
Left to right: Sanziana Negreanu Arboreanu, Salvatore Scalzo, Erik Vollebregt, Natalie Gladkov

“I think that the AI regulation still needs some calibrating,” said Erik Vollebregt, legal medtech expert and founding partner at Axon Lawyers (Netherlands), during a recent conference in Brussels.

He noted during a panel discussion that the commission’s draft AI regulation is based on the legal framework used for physical products, but

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