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CATÉGORIE: DOCUMENTATION
Identification unique des dispositifs (IUD)
Un système d'identification adéquate des dispositifs médicaux tout au long de la distribution et de l'utilisation. L'IUD comprend un identifiant de dispositif (IUD-ID) et un identifiant de production (IUD-IP).
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
Track regulatory signals related to Identification unique des dispositifs (IUD) across 27 authorities in real time.
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