CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 39915308.
- Also identified by DOI 10.1038/s41746-025-01459-8 and PMC identifier 11802784.
- Licence recorded as CC BY-NC-ND.
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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.