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唯一器械标识(UDI)
通过分销和使用充分识别医疗器械的系统。UDI由器械标识符（UDI-DI）和生产标识符（UDI-PI）组成。FDA、EU MDR和其他监管机构要求。
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
UDI systems identify devices through distribution and use. FDA UDI, EU MDR UDI, and other jurisdictions require device identifiers on labels and often database registration (GUDID, EUDAMED).
PROCESS / STEPS
- Assign UDI-DI (device model) via an FDA-accredited issuing agency (or EU-equivalent).
- Define UDI-PI production identifiers (lot, serial, expiry, manufacture date) as applicable.
- Place AIDC (barcode/RFID) and HRI (human readable) on labels/packaging per rule.
- Submit device identifier data to GUDID (US) and relevant EU modules when required.
- Maintain change control when packaging or device versions create new DIs.
EXAMPLES
- A sterile implant package carries UDI on the label and unit-of-use packaging hierarchy.
RELATED GUIDES & TOOLS
SOURCES
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