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EU: The EU AI Act Is Adding a New Layer of Regulation for AI-Enabled Medical Devices

9 January 2026

The regulatory environment for AI-enabled medical devices in the European Union has become increasingly complex with the introduction of the EU Artificial Intelligence Act (AI Act), which now sits alongside the Medical Devices Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR), and the General Data Protection Regulation (GDPR). This "regulatory lasagne" requires manufacturers to navigate numerous requirements to ensure that their AI-driven healthcare solutions are compliant.

For more information, see our publication here.

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News

EU: The EU AI Act Is Adding a New Layer of Regulation for AI-Enabled Medical Devices

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