EUDAMED FAQ: Excel, XML, XSD and upload errors

By the eudaflow team · Published: 2 October 2026

Whether Excel can be uploaded to EUDAMED, how UI, XML upload and M2M differ, why an XSD-valid file can still be rejected and how to read the response.

Preparing the data is one job and getting it into EUDAMED is another. These three questions are about the second. Each answer names its official source.

Can I upload an Excel file to EUDAMED?

No. The EUDAMED Information Centre describes three ways to enter data: the user interface, XML upload and machine-to-machine (M2M) data exchange. We found no page that accepts Excel or CSV as an input format. The only Excel files the Information Centre offers are the data dictionaries, which document the fields. Excel can be a working file in your own process, but the files EUDAMED takes are XML.

How the three ways differ:

User interface: manual input of data through the application.
XML upload: a semi-automated method. You can generate the XML files automatically, but uploading them stays a manual action. In the Bulk Upload screen you select a service and attach an XML file.
M2M: automatic data exchange between your own backend system and EUDAMED's backend services, in bulk as well. Your system must convert its data into EUDAMED's XML format and implement a specific exchange protocol, and a product that meets the eDelivery specifications must be installed on your side.

The Information Centre gives a rule of thumb for volume. Up to 100 devices: the user interface. From 100 to 1,000: bulk upload. More than 1,000: M2M. It is a suggestion, and the right method also depends on how often you submit and how your data is kept.

Sources: Guidelines on Data Exchange, purpose and requirements for the different modes of data input; M2M modes of data input and prerequisites; Bulk upload; Technical documentation. Last checked 29 September 2026.

My XML passed the XSD check. Will EUDAMED accept it?

Not necessarily. The XSD checks the structure of the XML. EUDAMED also applies business rules to the content when the data is submitted, and the records already in EUDAMED matter too. A file can be schema-valid and still be rejected.

What the documents show:

The XML data must be validated against the EUDAMED DTX service and entity model XSDs. The Information Centre lists the validation rules, such as field sizes and mandatory or optional fields, separately from the schema.
Business rules are conditions that are validated when information is submitted.
In a bulk upload, one object in a file can be processed while another is rejected for incorrect data or duplicate values.
EUDAMED checks the version number of a record: the version in the payload must be the next version stored in EUDAMED, otherwise it returns an error.
The XML files must declare the XSD version in use, or they are rejected. The current XSD schemas are version 3.0.30, for platform release 2.27.0.

Our own Playground tests show the gap. A reference number of 121 characters is allowed by the XSD, which permits 255, and EUDAMED rejected it with the message Size, because the data dictionary and the user interface allow 120. The full list is in our test report.

The XSD schemas, the business rules and the enumerations are published on the Information Centre's technical documentation page.

Sources: Guidelines on Data Exchange, purpose and requirements for the different modes of data input; UDI Devices business rules, section 2; Bulk upload; services definition for economic operators; M2M message exchange; Technical documentation; our Playground test report. Last checked 29 September 2026.

EUDAMED rejected my upload. How do I read the feedback?

Download the XML response file and read it object by object. EUDAMED processes each object in your request on its own and collects all the results in one response file. That file can hold SUCCESS lines for some objects and ERROR lines for others. Correct the source data behind the errors and resubmit only the objects that returned an error.

In practice:

After the upload, click Go to upload management to see your pending upload.
When processing has finished, a download link for the XML response appears in the Response column.
Read the result in that file. Keep it together with the XML you sent, so that each error can be matched to its object.

Error messages name a business rule, for example BR-DTX-UDI-099, "No device found". The UDI/Devices business rules document lists these rules. Some errors carry a longer code, such as ERR-BR-DTX-UDID-096.01-01. Those sub-codes appear in the services definition documents and not in the business rules PDF.

For M2M, EUDAMED's acknowledgement carries a status code and a report of processing statuses and details for each entity that was sent.

Sources: Bulk upload; M2M PUSH; UDI Devices business rules, BR-DTX-UDI-099; services definition for economic operators. Last checked 29 September 2026.

Sources and how we checked

Every statement above is tied to a quote in a claims register, and a script compares each quote with the current text of its source before we publish. The EUDAMED documents here are version 2.27.0 of 2026, and rules and screens can change with each release. This page is general information, not legal advice.