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CATEGORY: DOCUMENTATION
Unique Device Identification (UDI)
A system to adequately identify medical devices through distribution and use. UDI consists of a Device Identifier (UDI-DI) for the device model and a Production Identifier (UDI-PI) for the specific unit. Required by FDA, EU MDR, and other regulators.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 Unique Device Identification (UDI) across 27 authorities in real time.
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