Create XML for EUDAMED.
For new and registered devices.

UDI Studio creates the XML file that EUDAMED bulk upload requires. It lets you prepare device information together instead of entering each device separately in EUDAMED.

1. Choose new registration or changes to registered MDR devices.
2. Import your input, select devices and complete the information.
3. Review and download the XML file. The tool checks its structure automatically.
4. Sign in to EUDAMED, upload the file using the correct service and read the response.

Creating or downloading a file here does not register anything in EUDAMED. The registration or change is processed only after you upload the file there.

For new devices: an Excel or CSV list, already assigned BUDI and UDI-DI identifiers, the manufacturer’s SRN, a relevant EMDN code and device details such as risk class, market countries and information from the label or instructions for use.

For changes: current XML exports of the registered MDR devices from EUDAMED. These supply the existing values and version numbers. The update tool does not use an Excel list.

You do not need a UDI Studio account. To download exports and submit your finished file, you do need access to the relevant actor and service in EUDAMED.

• BUDI (Basic UDI-DI): identifies the device group in EUDAMED.
• UDI-DI: identifies a particular device or variant. It is a different identifier from BUDI and is not an individual item’s serial number.
• EMDN: the device category code in the European nomenclature.
• SRN: an actor’s registration number in EUDAMED, for example the manufacturer’s SRN.

The tool does not create new BUDI or UDI-DI identifiers. Use identifiers already assigned under your issuing entity’s rules.

Use a header row and one device per row. Three columns are needed: article/reference number, trade name and UDI-DI. For GS1, use a 14-digit GTIN as the UDI-DI.

Including separate BUDI and EMDN columns is recommended. They are not required columns, but each device must receive those values from the file or the manual fields before import can finish. After choosing your file, check which column supplies each item of information.

CSV uses semicolons (;) or commas (,). Tabs, spaces and full stops are not supported as column separators. Keep leading zeros. If a name contains the separator, enclose it in double quotation marks.

Article number;Trade name;UDI-DI
ART-001;Example device;01234567890128

This example shows the file format only. Replace it with your own device details and assigned identifiers. An Excel file (.xlsx) can be imported directly.

When you export, the tool automatically runs an XSD check in your browser. It checks that the XML follows the supplied official schema version 3.0.30, including its structure and data types. The schema is not fetched live from EUDAMED for every check.

Passing XSD means the file passed this check. It does not mean the device is registered or all information has been accepted. EUDAMED checks its registry, versions and business rules during upload. Always read EUDAMED’s response file.

You can download a validation report to keep with the XML file. Official schemas and rules are available from EUDAMED ↗

Imported files and device information are processed in your browser and are not uploaded to UDI Studio’s server. When you create XML, your browser downloads the file. Download the validation report separately if you want to keep it too.

Files go wherever your browser saves downloads, usually the Downloads folder. Reloading or changing language clears the current form and imported devices. Saved profiles remain unless the website’s browser storage is cleared.

The registration forms let you save up to 10 local profiles. First import the device list and choose a BUDI group. Complete the settings you want to reuse, name the profile and choose Save as new profile.

Next time, import the new list, select the group and profile and click Apply to form. Merely selecting a profile does not fill in the information. Always check that the values and dates are still correct.

Profiles contain reusable settings, not device lists, BUDI/UDI-DI identifiers or XML files. They are saved only in the same browser and on the same website. Export a JSON backup to transfer them or keep a copy. The update tool uses your imported EUDAMED exports and has no profile manager.