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类别: CLASSIFICATION
AI/ML医疗器械
使用人工智能或机器学习算法进行诊断、治疗决策或监测的医疗器械。FDA已发布AI/ML框架；EU MDR在现有SaMD分类规则下处理AI器械，并有额外的透明度要求。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
AI/ML-enabled medical devices raise unique issues around training data, bias, transparency, and predetermined change control plans for iterative updates.
PROCESS / STEPS
- Document model development, validation, and human factors.
- Define update strategy acceptable to regulators.
- Monitor drift and real-world performance.
- Report adverse events and manage field updates as needed.
EXAMPLES
- Radiology triage AI and ECG interpretation algorithms are common AI device categories.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to AI/ML医疗器械 across 27 authorities in real time.
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