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類別: DOCUMENTATION
技術文件
證明醫療器材滿足適用法規要求的全套文件。根據EU MDR，技術文件必須包括器材描述、設計和製造資訊、GSPR合規性、臨床評價和標籤。
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
Technical documentation is the evidence package demonstrating conformity—device description, design/manufacture, GSPR, benefit-risk, clinical evaluation, PMS, and labeling under EU MDR Annex II/III (and analogs elsewhere).
PROCESS / STEPS
- Structure docs per market templates (MDR Annex II/III, FDA submissions, etc.).
- Control versions and design history links.
- Ensure traceability from requirements to V&V.
- Keep NB/authority-ready access via EC REP/DMAL/MAH as applicable.
EXAMPLES
- A CER, risk file, and design dossier are core TD elements for implantable devices.
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SOURCES
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