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The output is validated against the EUDAMED v3.0.30 XSD before export, and against up to 133 checks across 43 validation rules, covering MDR, IVDR and the legacy directives, before delivery. That is what we check and what we stand behind. The upload itself stays with you: EUDAMate prepares the data, it does not submit it.

We don't use your files to train AI. What we keep is your EMDN decisions: the codes you approve or change, together with the device name, model, trade name and description. They join the matching list we build from the public EUDAMED database. Once a week we also use them to tune the weights of the formula that ranks EMDN suggestions. No customer ever sees another customer's device data. With a subscription your prepared device data stays in your account for as long as the subscription runs. One-off projects are deleted 60 days after your last export or within a day of marking them finished.

No. EUDAMate is a data preparation tool with no connection to EUDAMED. We map your device data to the EUDAMED field schema, classify EMDN codes, and validate against up to 133 checks across 43 validation rules. The result is a clean CSV you feed into your submission portal or tool. We are the step before submission, not submission itself.

Any tabular format: Excel (.xlsx, .xls), CSV, or TSV, including raw ERP exports. Column names can be in any language: German, French, Turkish, English. The mapping to 81 EUDAMED fields is handled for you.

Enough to start. Most ERPs hold a fraction of what EUDAMED wants, and a part number plus a description is normal. A legacy device needs 23 mandatory fields. We fill 17 of them from what you upload and list the rest field by field. We can't invent data you don't have. What we can do is tell you which fields are missing and where they usually come from, before you start instead of after a rejection.

The RDR is a PDF that names who approved each export. It records each AI suggestion with its confidence, every change anyone made with who and when, the reason for each override and the validation results. Each logged event is linked by SHA-256 to the one before it. Audit events cannot be edited in our database. Anyone holding the record can check its audit trail fingerprint at www.eudamate.eu/verify. File it in your QMS as the record of how your registration data was prepared.

Every AI suggestion comes with a confidence score: Green (high confidence, auto-approvable), Yellow (moderate, review suggested), or Red (low or missing, manual entry required). You see the alternatives and you can override any suggestion with a reason. Before export you confirm who approves it.

Yes. Legacy device support is a core focus. By November 27, 2026 every legacy device you are still placing on the EU market needs a EUDAMED record. Two things are out of scope. First, devices for which you place no further units on the EU market from 28 May 2026, the date the UDI/DEV module became mandatory. Second, legacy devices whose Regulation equivalent, MDR or IVDR, is already registered under the same UDI-DI, reference number or trade name, provided no change was made that assigns that Regulation device a new UDI-DI. The two exemptions come back differently. The first falls away if any post-market or vigilance action occurs. The second is narrower: the legacy device needs registering only where the action concerns the legacy device and not its registered Regulation equivalent (MDCG 2024-11, Q8 and Q14). The pipeline handles MDR, IVDR, MDD, AIMDD and IVDD, including the EUDAMED DI versus Basic UDI-DI distinction that legacy devices need.

Submission portals handle the upload to EUDAMED. They need clean, structured data to work. EUDAMate is the step before: we take your device data as it is and produce the clean CSV those portals expect. Complementary to your existing submission workflow, not a replacement.

If your file is rejected because of a mapping or validation error we produced, you get a full refund and a corrected file. Classification choices you approved yourself remain your own regulatory decision. Your RDR shows each one.