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類別: CLASSIFICATION
AI/ML醫療器材
使用人工智慧或機器學習算法進行診斷、治療決策或監測的醫療器材。FDA已發布AI/ML框架；EU MDR在現有SaMD分類規則下處理AI器材，並有額外的透明度要求。
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醫療器材 across 27 authorities in real time.
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