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How do I read and correct an EUDAMED XML response?

Find the response file, read each object’s result and prepare supported corrections without resubmitting successful objects.

1. Download the response from EUDAMED

  1. Open Data transfer → Bulk Upload.
  2. Open upload management and find your request. After an upload, you can use Go to upload management.
  3. Once processing is complete, click the XML link under Response. Keep both this file and the XML you submitted.

The response is different from a device export and from the submitted request. A processed upload can contain successful objects and objects with errors.

2. Read the result on this website

Open the response tool and choose one or more XML responses. The counts refer to response objects, not the number of error messages. Two error messages for one UDI-DI count as one object with errors. Separate uploads may refer to the same device.

Filter successful, failed or unclear results and open the exact original messages. Unknown codes and conflicting results are not presented as successful. The tool never invents an article number or a trade name that is absent from the response.

3. Download the Excel report

The report contains an overview, all objects, errors/unclear results and the original messages. UDI-DIs are text cells so leading zeros remain. Original long messages are split across rows if necessary. An Excel report is for review; it is not an EUDAMED upload file.

4. Add the original request only if correction is needed

Choose the exact XML originally submitted for one of your responses. The tool checks conversation/correlation IDs, service, actor and a unique mapping of every response object. It does not pair objects by row order. Missing or ambiguous matches block correction.

5. Correct supported errors

The first version supports EMDN for the precise documented code ERR-BR-UDID-636.05-01: the nomenclature code is not found or is not a leaf code. Only this field opens. Choose the code describing your device; the tool cannot decide your medical classification. If multiple codes are applicable, separate them with spaces.

This error mapping is documented in official release notes and tested with constructed responses. It has not yet been verified with a real rejected EMDN response for every service. Correction is limited to uniquely matched UDI_DI / POST and DEVICE / POST requests, XML version 3.0.30. Responses for other services can be read, but cannot be corrected here.

Unknown errors, registry/security issues, ambiguous identifiers, and objects with additional unsupported errors are excluded. Further editable error types can be added after their mappings are verified.

When an identifier already exists

Check the existing EUDAMED registration. If its data is correct, do not register it again. If data needs changing, use the update tool with a current EUDAMED export. Duplicate errors do not open identifier-editing fields and are excluded from resubmission.

6. Review and download the new XML

Select only the correctable objects you want to resend and edit their EMDN. Review the before/after values. Successful objects and all unselected or unsupported objects are removed; the other data of each selected object is preserved from the request. The new request gets new message IDs. The original files are not changed.

The complete new XML must pass the bundled XSD validation, and you must confirm before downloading. Editing a value afterwards clears this confirmation. Upload the new XML manually to the same EUDAMED service and read the new response.

XSD success does not prove EUDAMED acceptance. Existing BUDI state, identifier assignment, actor permissions and other business rules are checked by EUDAMED. No product data is sent automatically to EUDAMED or stored on this website; closing the page clears this work.

Read a response file →

Official sources