CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software.
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 Information
Frank E Rademakers: Emeritus Professor of Cardiology, KU Leuven, Leuven, Belgium. frank.rademakers@kuleuven.be. ORCID
Elisabetta Biasin: Researcher in Law, Center for IT & IP Law (CiTiP), KU Leuven, Leuven, Belgium. ORCID
Nico Bruining: Department of Cardiology, Erasmus Medical Center, Thorax Center, Rotterdam, the Netherlands. ORCID
Enrico G Caiani: Department of Electronics, Information and Biomedical Engineering, Politecnico di Milano, Milan, Italy. ORCID
Rhodri H Davies: Institute of Cardiovascular Science, University College London, London, UK.
Stephen H Gilbert: Professor for Medical Device Regulatory Science, Else Kröner Fresenius Center, for Digital Health, TUD Dresden University of Technology, Dresden, Germany.
Eric Kamenjasevic: Doctoral researcher in Law and Ethics, Center for IT & IP Law (CiTiP), KU Leuven, Leuven, Belgium.
Gearóid McGauran: Medical Officer, Medical Devices, Health Products Regulatory Authority, Dublin, Ireland. ORCID
Gearóid O'Connor: Medical Officer, Medical Devices, Health Products Regulatory Authority, Dublin, Ireland. ORCID
Jean-Baptiste Rouffet: Policy Advisor, European Affairs, European Federation of National Societies of Orthopaedics and Traumatology, Rolle, Switzerland.
Baptiste Vasey: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Alan G Fraser: Consultant Cardiologist, University Hospital of Wales, and Emeritus Professor of Cardiology, School of Medicine, Cardiff University, Heath Park, Cardiff, UK.
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.
References
J Med Internet Res. 2021 Oct 26;23(10):e30545
[PMID: 34697010]
