A UDI has two parts: the UDI-DI, which identifies the device model and packaging configuration, and the UDI-PI, which identifies the production unit, such as the lot, serial number or expiry date (see UDI-DI and Basic UDI-DI). The code appears in an automatic identification and data capture (AIDC) form, such as a linear barcode or Data Matrix, and in a human-readable form. Codes are issued by an accredited agency such as GS1, HIBCC or ICCBBA. In the US, device UDI data is submitted to GUDID, and in the EU to EUDAMED.
Why it matters for labeling
UDI applies at every packaging level, from the device or unit pack to the carton and case, and it was phased in by device class in both the US and the EU. Each level carries its own UDI-DI, so a label change at one level has to be carried through the others and into the database record.
Common mistakes
- Unit label updated but other packaging levels left as they were
- Barcode and human-readable text encoding different values
- Label and database record out of step
- Assuming the same UDI rules apply identically in the US and the EU