UDI Studio prepares an XML file: a structured request that EUDAMED can read. Downloading it does not register or update your devices. You upload it yourself in EUDAMED and check the response.
Before you start
- Have the generated XML, its validation report and access to the correct EUDAMED actor ready.
- Check whether your file concerns a new Basic UDI-DI (BUDI, the device group), new UDI-DI under an existing BUDI, or updates to registered UDI-DI.
- Keep the request and report together to identify exactly what you sent.
Upload and check the outcome
- Sign in with the appropriate actor/profile. Open Data transfer → Bulk Upload → New upload.
- Select the service matching the workflow shown in UDI Studio. A new-BUDI file, an existing-BUDI registration file and an update file use different services. For updates, choose Update of UDI-DI / Master UDI-DI.
- Attach the XML request in Step 1. Add related attachments in Step 2 only if the service requires them. Do not upload your source Excel or CSV instead of the generated XML.
- Follow processing in Upload Management. Download the response XML when it becomes available.
- Read the result for each object, not only the overall status. Check that the expected articles were accepted before starting another registration or update.
If only some articles succeed
One request can contain accepted and rejected objects. Correct and resubmit only rejected objects. Repeating the full file also repeats requests for articles that already succeeded. Keep the response with the original request. If the status remains Processing, do not repeatedly send copies while waiting: that status alone does not explain the delay.