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

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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Main Authors: 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
Format: Article
Language:English
Published: Nature Portfolio 2025-02-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-025-01459-8
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Summary: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.
ISSN:2398-6352

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