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Bruno Gago

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Review Open access Sep 2026

Challenges and Recommendations in Regulating AI Medical Devices in the European Union: A Scoping Review

Background/Objectives: The integration of artificial intelligence (AI) in medical devices has significant potential for transforming healthcare in the European Union (EU). However, AI medical devices are regulated under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR),...

Guilherme Semedo, Emanuel Valpaços, L. Teles et al. · 0 citations

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