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类别: CLASSIFICATION
分类规则
用于确定医疗器械风险类别的法规标准。EU MDR附录VIII包含22条基于持续时间、侵入性、有源/无源状态和预期用途的分类规则。FDA使用产品代码和咨询委员会。
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
Classification rules (e.g., EU MDR Annex VIII, IMDRF principles, national rule sets) determine device risk class and therefore pathway, clinical evidence, and audit intensity.
PROCESS / STEPS
- Identify all applicable rules; apply the strictest relevant class when multiple rules apply.
- Document borderline analysis and intended purpose carefully—classification follows claims and use.
- Reassess after design or indication changes.
- Align class with QMS, labeling, and economic operator duties.
EXAMPLES
- A software that provides diagnostic information may jump classes versus software that only stores data.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 分类规则 across 27 authorities in real time.
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