Summary
Explains how the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation apply alongside the AI Act to AI-enabled medical devices, including roles, high-risk classification, conformity assessment, clinical evidence, post-market obligations, and real-world testing.
Healthcare Implications
Manufacturers, notified bodies, and healthcare deployers should map both regimes and coordinate documentation, quality systems, evidence, conformity, and monitoring. AI Act high-risk status does not itself change a device’s MDR or IVDR classification.