EUDAMED UDI error library:

Top 25 Returns (Symptom → Cause → Fix → Prevention)

This bug library is intended for Regulatory Affairs & Quality to quickly classify returns, control corrections cleanly and incorporate prevention into the process. Use the structure per error: symptom, probable cause, RA/QA quick fix, prevention control.

Practical tip: Create an “error board” internally (Jira/Excel) that maps each return to exactly one library entry. This way, recurring errors become visible and disappear permanently.

1) Master data & identifiers

1. SRN is missing or inconsistent

  • Symptom: Record is rejected or remains under review.
  • Cause: SRN not maintained / wrong actor (manufacturer vs. authorized representative).
  • Quick Fix: Set SRN source, entry consistent across all relevant records.
  • Prevention: Define field owner, mandatory field check before submission.

2. Basic UDI-DI and UDI-DI not cleanly linked

  • Symptom: UDI-DI is not accepted or “parent” is missing.
  • Cause: Parent code not maintained or spelling/format deviating.
  • Quick Fix: Create the master list Basic UDI-DI and use it as a reference.
  • Prevention: Lookup validations (only allow existing parent codes).

3. Issuing Agency /Code Format Inconsistent

  • Symptom: “Invalid code” / format error.
  • Cause: Issuing body (e.g. GS1/HIBCC/ICCBBA) not correctly or code incorrectly structured.
  • Quick Fix: Check the allocation point per product line, harmonise code formats.
  • Prevention: Drop-down selection + regex/format checks (Excel) and validation before submission.

2) Classification, Legislation, Equipment Characteristics

4. MDR/IVDR legislation set incorrectly

  • Symptom: Contradictions in mandatory fields or rejection.
  • Cause: Record uses MDR logic in IVDR or vice versa.
  • Quick Fix: Check applicable legislation and correct dependent fields.
  • Prevention: “Legislation Gate”: release dependent fields only in appropriate logic.

5. Contradictory risk class / characteristics

  • Symptom: Data set not plausible (e.g. implant flag vs. class).
  • Cause: Classification not coordinated with device flags.
  • Quick Fix: Check classification matrix (RA/QA) against device attributes.
  • Prevention: Review checklist: Check risk class + central flags together.

3) UDI-DI, Status, Names & Models

6. Device name/model inconsistent across variants

  • Symptom: Variants difficult to understand, data seem inconsistent.
  • Cause: Naming conventions are missing (marketing vs. engineering vs. labeling).
  • Quick Fix: Define naming SOP (Device Name vs. Model vs. Reference).
  • Prevention: “Golden Values” from a System of Record; Approval by RA/QA.

7. Device status incorrect or not maintained

  • Symptom: Refusal / conflicts with updates.
  • Cause: Active/inactive logic not clear; old variants remain active.
  • Quick Fix: Set status definition and clean affected records.
  • Prevention: Change process: Status change only via release + evidence.

4) Packaging Hierarchy & Child UDIs

8. Packaging levels incomplete

  • Symptom: Declines in packaging structures.
  • Cause: Child UDI or quantity information missing; hierarchy not consistent.
  • Quick Fix: Model packaging levels as a tree (level 0/1/2 …), check quantities per level.
  • Prevention: Packaging checklist: level, UDI, quantity, status, relationship.

9. Unit of Use / Secondary Identifiers applied incorrectly

  • Symptom: Unclear identifiers, inconsistencies.
  • Cause: Unit of Use vs. Packaging not cleanly separated.
  • Quick Fix: Clarify terms internally and define rules per product family.
  • Prevention: Document field guidance directly in the template (comment/help text).

5) Production Identifiers (PI): Lot/Serial/Expiry/Manufacturing

10. PI fields are “possible” instead of “actually” maintained

  • Symptom: Data does not match the label / real production process.
  • Cause: Confusion “PI may occur” vs. “PI is on the label”.
  • Quick Fix: Set PI decision based on actual labeling.
  • Prevention: Define labeling owner as data owner for PI logic.

6) Certificates, NB & Revisions

11. Certificate number/revision number unclear

  • Symptom: Queries or inconsistencies when purchasing a certificate.
  • Cause: Revisions/extensions not neatly versioned.
  • Quick Fix: Set up certificate register (no., rev., type, NB code, runtime).
  • Prevention: Change process: Certificate changes trigger UDI review.

7) Process error (the most common “invisible” causes)

12. Data changes without approval

  • Symptom: Returns are repeating; audit evidence is missing.
  • Cause: No formal review/approval mechanism.
  • Quick Fix: Make RA/QA release step mandatory before each submission.
  • Prevention: Use workflow with audit trail and roles (portal/SAP add-on).

13. “Submission Success” will not be archived

  • Symptom: Audit/inspection lacks evidence, although technically submitted.
  • Cause: Result files/government responses are not backed up centrally.
  • Quick Fix: Introduce evidence filing for each submission run (zip/reports/logs).
  • Prevention: Evidence SOP (monthly/per run) + naming convention.

The remaining 12 errors (short format)

Use this list as a “fast check”. If you wish, I can formulate each point analogous to above (symptom/cause/fix/prevention).

  1. Direct marking information is missing or contradictory.
  2. Latex/human/animal tissue flags implausible.
  3. IVDR specifics (e.g. self-testing) are missing despite IVDR labelling.
  4. Language not consistent with product information provided.
  5. Storage & handling conditions incomplete.
  6. Device labelled as sterile / needs sterilization before use contradictory.
  7. Reusable surgical instrument flag set incorrectly.
  8. Reference number/material number duplicate or not unique.
  9. Packaging status differs from device status without justification.
  10. Multiple UDI DIs are inadvertently listed as identical.
  11. Data export/import creates tacit format changes (e.g. leading zeros).
  12. Updates are submitted as a “new creation” instead of a change.

Next step

If you want to systematically reduce returns, combine
Excel template with the Global Submission Portal
or – in the case of SAP governance – Global UDI Add-on for SAP.

FAQ

How do I interpret technical validation errors as RA/QA?

Always work with the logic “What exactly is affected?” (Field/Section), “Which rule is being violated?” and “What source is Owner?”. Ideally, you will get errors localized in such a way that corrections are possible without XML special knowledge.

How do I make sure an error doesn’t come back?

Every error must have a prevention check: template validation, mandatory field gate, approval process or automated check before submission. Once you standardize this, the return rate decreases significantly.