Import your file
Use Excel or CSV for new devices and a current EUDAMED XML export for updates.
Prepare your devices for EUDAMED
Create XML files for new registrations or update existing MDR devices. Import your data, complete the details and download the file to upload to EUDAMED.
- Files are processed in your browser
- No installation or sign-in needed
Start here
Choose a tool
For registrations and updates: select the device regulation, then choose your task.
Which situation applies to you?
New devices under an existing BUDI
The device group is already registered in EUDAMED. Add more devices from an Excel or CSV list.
New BUDI with one first device
The device group is not registered yet. Prepare one file for the BUDI and a single first UDI-DI.
Change registered devices MDR only
Import current XML exports from EUDAMED and choose which information to change.
Each XML file covers one BUDI group. You review the information before creating the file.
New devices under an existing BUDI
The device group is already registered in EUDAMED. Add more devices from an Excel or CSV list.
New BUDI with one first device
The device group is not registered yet. Prepare one file for the BUDI and a single first UDI-DI.
The IVDR options are for new registrations. The update tool currently supports registered MDR devices only.
XML → Excel
Already uploaded a file to EUDAMED?
Read the XML response, understand the result and download a clear Excel report. Use the submitted XML file to correct supported errors.
Need a template? Excel/CSV templates and examples are available in the form’s import step. See how to prepare your article list →
Search public EUDAMED data
Find actors and devices by company name or identifier. View manufacturer BUDI groups and open the result in EUDAMED. Search queries are sent to the public API via UDI Studio.
How it works
Complete and review
Select devices and complete the details. The tool checks the XML file against the XSD schema automatically.
Download and upload
Download the XML file and upload it yourself to EUDAMED. Then read the response file to see the result.
Practical guides
Upload XML to EUDAMED
Choose the right service and check the result.
Read guidePrepare Excel or CSV
Columns, file formats and examples for your article list.
Read guideUnderstand Basic UDI-DI and UDI-DI
Choose a new device family or an existing Basic UDI-DI.
Read guideUpdate MDR devices
Start with current XML exports and choose your changes.
Read guideUnderstand validation and errors
What the XSD check covers and what EUDAMED checks.
Read guideCreate and check a GS1 Basic UDI-DI
Company prefix, model reference and two check characters.
Read guideRead and handle response files
Understand results, download Excel and correct supported errors.
Read the guide →Common questions
What should I have ready?
For registration: an article list, assigned Basic UDI-DI and UDI-DI codes, manufacturer SRN, EMDN and device details. Basic UDI-DI or EMDN values missing from the file can be entered in the form.
For updates: current XML exports from EUDAMED. For the response reader: the XML response and, to correct supported errors, the original submitted XML file too.
What do BUDI, UDI-DI, EMDN and SRN mean?
BUDI (Basic UDI-DI) identifies the device family. UDI-DI identifies a specific device or variant. EMDN classifies the device type. SRN identifies an actor in EUDAMED, such as the manufacturer.
UDI Studio does not assign identifiers. Use codes assigned through your issuing entity.
Does passing validation guarantee acceptance?
No. The automatic XSD check covers structure and data types against bundled schema 3.0.30. EUDAMED also checks registry data, permissions and business rules. Always read the response file after uploading.
Where is my data saved?
Article files and XML are processed in your browser and are not uploaded to UDI Studio’s server. Completed files are downloaded to your computer. Reloading or changing language clears the current form.
Can I save settings for next time?
Yes. Registration forms can save up to 10 local profiles in the same browser. Profiles contain reusable settings, not article lists or XML files. Export a profile backup to move them. The update tool uses data from your XML export.
UDI Studio is an independent tool, not an official EU service. It supports standard MDR/IVDR registrations, MDR device updates and response-file reading. Legacy devices, Master UDI-DI and system/procedure packs are not included.