Fraser, Alan G.Biasin, ElisabettaBijnens, BartBruining, NicoCaiani, Enrico G.Cobbaert, KoenDavies, Rhodri H.Gilbert, Stephen H.Hovestadt, LeoKamenjasevic, ErikKwade, ZuzannaMcGauran, GearóidO’Connor, GearóidVasey, BaptisteRademakers, Frank E.2025-04-282025-04-282023Fraser AG, Biasin E, Bijnens B, Bruining N, Caiani EG, Cobbaert K, et al. Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiatives. Expert Rev Med Devices. 2023 Jun 3;20(6):467-91. DOI: 10.1080/17434440.2023.21846851743-4440http://hdl.handle.net/10230/70215Introduction. Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed. Areas covered. AI systems may qualify as standalone medical device software (MDSW) or be embedded within a medical device. Within the European Union (EU) AI software must undergo a conformity assessment procedure to be approved as a medical device. The draft EU Regulation on AI proposes rules that will apply across industry sectors, while for devices the Medical Device Regulation also applies. In the CORE-MD project (Coordinating Research and Evidence for Medical Devices), we have surveyed definitions and summarize initiatives made by professional consensus groups, regulators, and standardization bodies. Expert opinion. The level of clinical evidence required should be determined according to each application and to legal and methodological factors that contribute to risk, including accountability, transparency, and interpretability. EU guidance for MDSW based on international recommendations does not yet describe the clinical evidence needed for medical AI software. Regulators, notified bodies, manufacturers, clinicians and patients would all benefit from common standards for the clinical evaluation of high-risk AI applications and transparency of their evidence and performance.application/pdfeng© 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent.info:eu-repo/semantics/articlehttp://dx.doi.org/10.1080/17434440.2023.2184685Medical devicesProfessional consensus recommendationsStandards regulationsEU medical device regulationArtificial intelligenceEvidence-based medicineMachine learninginfo:eu-repo/semantics/openAccess