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類別: CLASSIFICATION
分類規則
用於確定醫療器材風險類別的法規標準。EU MDR附錄VIII包含22條基於持續時間、侵入性、有源/無源狀態和預期用途的分類規則。FDA使用產品代碼和諮詢委員會。
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
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