Basic UDI-DI is used as a regulatory grouping identifier. UDI-DI identifies a specific device model or version. Both should be kept consistent with declarations, certificates, labels, and EUDAMED-ready information.
Do not treat UDI as only a label barcode question. The identifiers connect technical documentation, certificates, registration information, and market traceability.
If identifiers are not assigned yet, record that as a gap. Your expert can still review other parts of the file, but final publication and registration inputs may remain blocked.
Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.