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<p>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.</p>

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年2月6日

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  • 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

摘要

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.