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Medical devices to get softer AI compliance regime, EU Commission proposes

By Luca Bertuzzi ( December 17, 2025, 07:02 GMT | Insight) -- Manufacturers of medical devices would see compliance with the EU AI Act's high-risk regime eased under a European Commission proposal. Part of a broader update to medical-device laws, it reflects longstanding industry concerns and would lower regulatory burdens for the medical technology sector if confirmed by EU lawmakers and governments.The European Commission has proposed changes to several laws governing medical devices, including an amendment that would simplify AI Act compliance for manufacturers....

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