UDI

UDI (Unique Device Identification) is the regulator-mandated identifier system that puts a globally unique, machine-readable code on every medical device and its packaging so it can be tracked from manufacture through clinical use, recall, and disposal. The UDI bundles a Device Identifier (DI) for the model and a Production Identifier (PI) for the lot, serial, expiration, or manufacture date.

What it covers

• DI + PI structure — static device identifier plus dynamic production identifier on the same code.
• Issuing-agency carriers — GS1, HIBCC, ICCBBA encodings, typically delivered as a GS1-128 or DataMatrix on label and direct part marking.
• Database submission to the FDA GUDID and the EU EUDAMED registries.
• Lifecycle linkage — UDI in DHR records ties as-built lots to clinical complaint, recall, and adverse event reports.
• Regulatory scope — required by 21 CFR Part 830 in the US, MDR/IVDR in the EU, and equivalent frameworks in other jurisdictions.

Relationships (see sidebar)

• Conforms to 21 CFR Part 820, EU MDR, and EU IVDR.
• Dependency of the QMS, DHF, and DHR capabilities for medical-device manufacturers.
• Supports the Regulatory Submission and Warranty and Field Feedback processes.