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

Vollständiger Abstract

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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), as well as horizontal legislation such as the AI Act, resulting in a multilayered framework that raises difficulties for all stakeholders. This scoping review aims to identify and classify the challenges associated with the regulation of AI medical devices in the EU and the corresponding recommendations proposed in the academic literature. Methods: This review followed the PRISMA-ScR guidelines. The search was conducted in February 2026 in Web of Science, Scopus, MEDLINE PubMed, and IEEE Xplore. Challenges and recommendations were extracted through an analytical review process and grouped into secondary and primary domains, and a composite indicator was developed to assess the predominance of each domain. Results: Seventy studies published between 2018 and 2025 were included. A total of 261 challenges and 113 recommendations were identified and organized in five primary domains: regulatory framework, data issues, accountability and ethics, development and deployment, and certification. The regulatory framework was the domain most frequently reported, reflecting the overlap between the MDR, the AI Act, and other legislation and the absence of harmonized standards. Transparency was the only secondary domain where recommendations outnumbered challenges. Conclusions: This review structures the fragmented evidence into a single framework, mapping areas most frequently discussed in the literature and identifying where recommendations are still scarce, and it provides a foundation for policymaking and regulatory science on AI medical devices in the EU.