UDI Data Submission to EUDAMED:

Decision Support for Regulatory Affairs & Quality

When UDI submissions fail, it is rarely because of “too few fields.” In practice, the drivers are data quality, rejections/returns, missing traceability/evidence, and an unclear operating process. This page helps you choose the right approach—and also provides a pragmatic RA/QA project plan including typical error patterns.

Decide in 2 minutes:

  • Excel Template – if you want to capture data in a structured way, review internally, and prepare cleanly.
  • Global Submission Portal – if you need submission, status, error handling, and evidence without an SAP project.
  • Global UDI Add-on for SAP – if governance, roles, approvals, and automation should be implemented in the SAP core.

Overview of the three approaches

Criterion Excel Template Global Submission Portal Global UDI Add-on
Main benefit for RA/QA Structured data capture + internal review foundation Validation + submission workflow + status + evidence Governance, roles, approvals, audit trail + authority plugins
IT dependency Low Low Medium to high (SAP context)
Scalability Good as an entry point / for preparation Good for recurring submissions Excellent for large portfolios + long-term operations
Error handling Manual (review + correction loop) Detailed validation errors + status phases Approval process + history + reuse of data
Evidence / audit File versioning, review records, backups Download packages (ZIP/reports) + audit trail Audit trail across approvals + user authorizations + history

Decision logic (practical)

1) Start with Excel if …

  • You first need to consolidate data from multiple sources (ERP, labeling, R&D, QM).
  • You want to establish a clean internal review and approval loop before the technical submission topics begin.
  • You need a clear “single source” dataset that can later be used for submission/automation.

2) Use the portal if …

  • You want to operationalize submissions without a major IT project.
  • You want to transparently control status, rejections/returns, and corrections.
  • You need an “evidence package” (reports/authority responses/logs) per run.

3) Use the SAP Add-on if …

  • UDI governance, roles, and approvals should be permanently embedded in the SAP process.
  • Multiple countries/authorities are managed via plugins and data should be reused.
  • You are focused on long-term automation and a process-level audit trail.

Typical rejections/returns: the 12 most common causes (and what RA/QA can do immediately)

  1. Inconsistent master data (e.g., product family vs. individual product) → clarify the data model and make parent/child relationships explicit.
  2. Invalid codes / issuing agency information → verify that format and issuing entity are consistent.
  3. Risk class / legislation inconsistent → centrally verify MDR/IVDR assignment and classification.
  4. Language / intended purpose information missing → define “where is which statement visible?” (label/IFU/EUDAMED).
  5. Incomplete packaging hierarchy → maintain child UDI, quantities, and packaging levels consistently.
  6. PI information misinterpreted → separate “possible PI” from “actually on the label.”
  7. Incomplete certificate data → maintain NB, certificate type, validity period, and revision cleanly.
  8. Contradictory device status → define active/inactive logic and the change process.
  9. Unclear direct marking information → fix DM rules internally (when DM-DI, when “same as”).
  10. Multiple data sources provide different truths → define the “system of record” per field.
  11. Changes without a controlled update process → introduce an update SOP with approval & evidence.
  12. Missing evidence/traceability → standardize the evidence set per submission (see evidence guide).

Further resources: Use our error library (Top 25 rejections/returns) and the Evidence Pack Guide to standardize corrections and evidence.

RA/QA project plan (compact, audit-ready)

Phase 1: Scope & data inventory

  • Define portfolio & product family structure (Basic UDI-DI → UDI-DI)
  • Define source systems per field (owner matrix)

Phase 2: Data capture & review

  • Capture in the Excel Template (or SAP data model)
  • RA/QA review loop: completeness, consistency, approval

Phase 3: Pilot submission & correction loop

  • Pilot scope (e.g., 1 product family + representative UDI-DIs)
  • Validation/submission (portal or add-on) → systematically work through rejections/returns

Phase 4: Rollout & operations

  • Routine for new creations & updates (change process)
  • Evidence archiving (monthly/per run)

Next step

Excel Template |
Global Submission Portal |
Global UDI Add-on

FAQ

When is an Excel template sufficient—and when do I need a portal?

Excel is ideal for capturing data in a structured way and making it review-ready. As soon as submission, status, rejection/return handling, and evidence need to be standardized, a submission workflow makes sense.

How do I reduce rejections/returns the fastest?

Define field owners, establish an RA/QA review loop, and standardize corrections via an error library (symptom → cause → fix). Then scale with a repeatable submission process.

What evidence does an auditor typically expect?

Approvals, versioning, proof of submission (status/authority responses), validation reports, and an audit trail of changes and user activities.

How do I handle updates to existing records?

Set up a change process: reason for change, affected fields, review/approval, submission run, evidence filing. This is often more important than the initial upload.