| Title: |
CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software |
| 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 |
| Source: |
npj Digital Medicine, Vol 8, Iss 1, Pp 1-11 (2025) |
| Publisher Information: |
Nature Portfolio, 2025. |
| Publication Year: |
2025 |
| Collection: |
LCC:Computer applications to medicine. Medical informatics |
| Subject Terms: |
Computer applications to medicine. Medical informatics; R858-859.7 |
| 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. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2398-6352 |
| Relation: |
https://doaj.org/toc/2398-6352 |
| DOI: |
10.1038/s41746-025-01459-8 |
| Access URL: |
https://doaj.org/article/b4e6e0db4f504cfdb94b29fe10f5f07f |
| Accession Number: |
edsdoj.b4e6e0db4f504cfdb94b29fe10f5f07f |
| Database: |
Directory of Open Access Journals |