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 manufacturing or expiry date). Under EU MDR, the Basic UDI-DI is the primary identifier of a device model in EUDAMED and appears on certificates and declarations of conformity, but not on the label. Each packaging level has its own UDI-DI.
Why it matters for labeling
The UDI-DI on the label, in barcode and human-readable form, has to match what is registered for that device and packaging level. A label change that alters the configuration changes the UDI-DI, and the change has to reach every packaging level and the registration record.
Common mistakes
- Unit label updated but intermediate or case labels not
- Human-readable text and barcode encoding different values
- Confusing the Basic UDI-DI, which isn't on the label, with the UDI-DI
- Label and EUDAMED record out of step
Sources
Related reading
GUIDE
UDI Labeling Requirements: What Medical Device Manufacturers Need on Every Label
UDI requirements under EU MDR and FDA — what must appear on every packaging level, EUDAMED deadlines, and the errors that cause non-conformities.
Read the guide →
ARTICLE
What EU MDR Actually Means for Your Device Label — And What Teams Keep Missing
Discover the critical labeling changes under EU MDR that medical device teams often overlook, ensuring compliance and avoiding costly audit findings.
Read the article →