A Unique Device Identifier comprises two parts: the Device Identifier (UDI-DI), a static code identifying the labeler and device version, and the Production Identifier (UDI-PI), conveying lot/batch, serial, expiration, or manufacturing date. In the US, the DI is submitted to FDA's GUDID database, while the PI stays on the label and in production records. In the EU, the Basic UDI-DI groups device models in EUDAMED and the UDI-DI identifies each package level. Issuing agencies such as GS1, HIBCC and ICCBBA provide the code formats, and changes to certain device features require a new DI.

Why it matters

EU MDR introduced the Basic UDI-DI as the master key for regulatory documentation in EUDAMED. Mismatched DI/PI assignments are a common cause of EUDAMED registration errors.

Common pitfalls

•Assigning an incorrect UDI-DI to a device version can lead to significant regulatory non-compliance and recall issues.
•Failing to accurately link UDI-PI data to the correct UDI-DI in regulatory submissions creates data integrity problems.
•Using UDI-PI elements inappropriately, such as using a lot number field for a serial number, can result in supply chain disruptions.
•Not updating UDI-DI data when device design changes occur leads to outdated and misleading product identification.
•Disregarding the Basic UDI-DI as the primary key for device registration in EUDAMED can cause extensive administrative burdens.

Sources

FDA UDI · FDA
GHTF/IMDRF Process Validation Guidance · IMDRF/GHTF
FDA - Device Manufacturing · FDA

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