CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software
Abstract The European CORE–MD consortium (Coordinating Research and Evidence for Medical Devices) proposes a score for medical devices incorporating artificial intelligence or machine learning algorithms. Its domains are summarised as valid clinical association, technical performance, and clinical p...
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2025-02-01
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| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-025-01459-8 |
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| author | Frank E. Rademakers Elisabetta Biasin Nico Bruining Enrico G. Caiani Rhodri H. Davies Stephen H. Gilbert Eric Kamenjasevic Gearóid McGauran Gearóid O’Connor Jean-Baptiste Rouffet Baptiste Vasey Alan G. Fraser |
| author_facet | Frank E. Rademakers Elisabetta Biasin Nico Bruining Enrico G. Caiani Rhodri H. Davies Stephen H. Gilbert Eric Kamenjasevic Gearóid McGauran Gearóid O’Connor Jean-Baptiste Rouffet Baptiste Vasey Alan G. Fraser |
| author_sort | Frank E. Rademakers |
| collection | DOAJ |
| description | Abstract The European CORE–MD consortium (Coordinating Research and Evidence for Medical Devices) proposes a score for medical devices incorporating artificial intelligence or machine learning algorithms. Its domains are summarised as valid clinical association, technical performance, and clinical performance. High scores indicate that extensive clinical investigations should be undertaken before regulatory approval, whereas lower scores indicate devices for which less pre-market clinical evaluation may be balanced by more post-market evidence. |
| format | Article |
| id | doaj-art-b4e6e0db4f504cfdb94b29fe10f5f07f |
| institution | Kabale University |
| issn | 2398-6352 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Digital Medicine |
| spelling | doaj-art-b4e6e0db4f504cfdb94b29fe10f5f07f2025-02-09T12:55:41ZengNature Portfolionpj Digital Medicine2398-63522025-02-018111110.1038/s41746-025-01459-8CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device softwareFrank E. Rademakers0Elisabetta Biasin1Nico Bruining2Enrico G. Caiani3Rhodri H. Davies4Stephen H. Gilbert5Eric Kamenjasevic6Gearóid McGauran7Gearóid O’Connor8Jean-Baptiste Rouffet9Baptiste Vasey10Alan G. Fraser11Emeritus Professor of Cardiology, KU LeuvenResearcher in Law, Center for IT & IP Law (CiTiP), KU LeuvenDepartment of Cardiology, Erasmus Medical Center, Thorax CenterDepartment of Electronics, Information and Biomedical Engineering, Politecnico di MilanoInstitute of Cardiovascular Science, University College LondonProfessor for Medical Device Regulatory Science, Else Kröner Fresenius Center, for Digital Health, TUD Dresden University of TechnologyDoctoral researcher in Law and Ethics, Center for IT & IP Law (CiTiP), KU LeuvenMedical Officer, Medical Devices, Health Products Regulatory AuthorityMedical Officer, Medical Devices, Health Products Regulatory AuthorityPolicy Advisor, European Affairs, European Federation of National Societies of Orthopaedics and TraumatologyNuffield Department of Surgical Sciences, University of OxfordConsultant Cardiologist, University Hospital of Wales, and Emeritus Professor of Cardiology, School of Medicine, Cardiff University, Heath ParkAbstract The European CORE–MD consortium (Coordinating Research and Evidence for Medical Devices) proposes a score for medical devices incorporating artificial intelligence or machine learning algorithms. Its domains are summarised as valid clinical association, technical performance, and clinical performance. High scores indicate that extensive clinical investigations should be undertaken before regulatory approval, whereas lower scores indicate devices for which less pre-market clinical evaluation may be balanced by more post-market evidence.https://doi.org/10.1038/s41746-025-01459-8 |
| spellingShingle | Frank E. Rademakers Elisabetta Biasin Nico Bruining Enrico G. Caiani Rhodri H. Davies Stephen H. Gilbert Eric Kamenjasevic Gearóid McGauran Gearóid O’Connor Jean-Baptiste Rouffet Baptiste Vasey Alan G. Fraser CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software npj Digital Medicine |
| title | CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software |
| title_full | CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software |
| title_fullStr | CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software |
| title_full_unstemmed | CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software |
| title_short | CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software |
| title_sort | core md clinical risk score for regulatory evaluation of artificial intelligence based medical device software |
| url | https://doi.org/10.1038/s41746-025-01459-8 |
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