Avoiding Rejected EUDAMED Batches
19 August 2026
Five things that reject EUDAMED bulk upload batches most often — and how to catch them before you submit, not after.
- Incorrectly formatted UDI-DI — Each issuing agency (GS1, HIBCC, ICCBBA) has its own formatting rules, and EUDAMED validates against the specific agency’s standard. A UDI that looks fine to you can still fail their format check.
- Missing conditionally required fields — Some fields are only mandatory depending on other values you’ve entered — easy to miss if you’re filling in a spreadsheet without knowing which conditions apply.
- EMDN code mismatches — Wrong or outdated EMDN codes at the UDI-DI level are one of the most common structural rejections.
- Risk class vs. conformity assessment mismatch — Your declared risk class needs to match the conformity assessment route on your actual certificate — inconsistencies here can stall a device indefinitely.
- Treating it as a data export, not a regulatory submission — Pulling fields straight from an ERP system and uploading them rarely works. EUDAMED expects structured, validated regulatory data — not raw product data.
The good news: EUDAMED processes each record independently, so one bad row doesn’t sink the whole batch — but you still have to find and refile it. Catching these before upload, not after, is the whole point of validating first.