CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software.

Rademakers, Frank E., Biasin, Elisabetta, Bruining, Nico, Caiani, Enrico G., Davies, Rhodri H., Gilbert, Stephen H., Kamenjasevic, Eric, McGauran, Gearóid, O'Connor, Gearóid, Rouffet, Jean-Baptiste, Vasey, Baptiste and Fraser, Alan G. 2025. CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software. npj Digital Medicine 8 (1) , 90. 10.1038/s41746-025-01459-8

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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.

Item Type:	Article
Status:	Published
Schools:	Schools > Medicine
Additional Information:	License information from Publisher: LICENSE 1: Title: cc by-nc-nd, Type: cc by-nc-nd
Publisher:	Nature Research
Date of First Compliant Deposit:	18 February 2025
Last Modified:	18 Feb 2025 11:45
URI:	https://orca.cardiff.ac.uk/id/eprint/176281

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