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R. van Stokkum

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Review Open access Oct 2026

When are large language models medical devices? Navigating the MDR and AI Act for healthcare applications

Abstract The flexibility of generative artificial intelligence (AI), and specifically large language models (LLMs), holds promise to transform healthcare by offering new tools to improve patient care and enhance clinician efficiency. However, this flexibility introduces new challenges, as LLM applications might inadver...

J. Workum, Sade J. Krijgsman, I. Vajda et al. · 1 citation

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