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類別: DOCUMENTATION
一般安全和性能要求(GSPR)
EU MDR附錄I中醫療器材必須滿足的基本要求。GSPR取代了MDD的基本要求，涵蓋化學/物理/生物特性、感染控制、輻射、電子設備、軟體和標籤。
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
General Safety and Performance Requirements (EU MDR Annex I) replaced MDD Essential Requirements and define what devices must meet for CE conformity.
PROCESS / STEPS
- Map each applicable GSPR to evidence in technical documentation.
- Link risk controls and clinical evaluation to GSPR claims.
- Update GSPR checklist after design/labeling changes.
EXAMPLES
- Software devices emphasize GSPR sections on IT security and information supplied by the manufacturer.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 一般安全和性能要求(GSPR) across 27 authorities in real time.
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