Navigating the EU AI Act: implications for regulated digital medical products

Abstract

The integration of artificial intelligence (AI) into regulated digital medical products is expected to transform the landscape of healthcare diagnosis. Both US and European Patent Office data show robust and rising patenting of medical AI inventions, reflecting an increased level of innovation at the invention stage 1 . These developments are not limited to early-stage innovation; they are now paralleled by a significant surge in actual practical applications of AI in healthcare, resulting in the development and market introduction of a new generation of commercially available medical AI products. The number of medical devices incorporating AI/ML continues to increase. In fact, the U.S. Food and Drug Administration (FDA) has already reviewed and authorized over 690 AI/ML-enabled medical devices, underscoring the growing importance of this technology in clinical settings 2 .

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