Unique Device Identification (UDI) is a system that uses an alphanumeric code to uniquely identify a medical device through its distribution and use. It comprises a Device Identifier (DI) and a Production Identifier (PI), and is registered in the GUDID (US) or EUDAMED (EU). The DI identifies the labeler and the specific version or model, while the PI can carry lot, serial number, expiry and manufacture date. The code must appear on labels in both plain text and automatic identification and data capture (AIDC) form, such as a barcode.

Why it matters

UDI supports recall management, adverse event reporting, and supply chain traceability. It is mandatory in the U.S., EU, and an increasing number of jurisdictions. The Device Identifier (DI) is the fixed portion that identifies the labeler and specific version or model. The Production Identifier (PI) is a conditional, variable portion that may include lot or batch number, serial number, expiration date, manufacturing date, and (for HCT/Ps) the distinct identification code.

Common pitfalls

•Confusing UDI-DI with UDI-PI. Regulators, GUDID, and EUDAMED all expect both to be handled correctly on labels and in submissions.
•Assuming a single UDI covers every package level. Each package configuration (unit, box, case) needs its own DI.
•Not updating GUDID or EUDAMED when labeling, sterilization method, or configuration changes.
•Treating UDI as a labeling-only task. It touches PLM, ERP, regulatory, and post-market systems.

Sources

UDI System (FDA) · FDA
AccessGUDID · NIH / FDA
EU UDI (MDR) · European Commission

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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