EUDAMED XML Creator

Instructions

Download Template

Important Notes

Use Playground

Always perform the upload in the EUDAMED playground first. This prevents incorrect medical device data from being uploaded to the live version, which may be difficult or impossible to correct later.

Status «Upload Limit»: According to EUDAMED, it is theoretically possible to upload up to 300 Basic UDIs, 300 UDI-DIs, 300 product designers, and 300 packages. However, in practice, it is possible that a validation error may occur with more than 25 entries.

Data Protection

The EUDAMED XML Creator App is a Stateless Web App. It does not permanently store any user data and does not share it with third parties. Only a temporary session for language selection is used. All uploaded Excel files and generated XML data are processed in memory only and are completely deleted when refreshing the page or closing the browser. The app does not use a database and does not store any information about medical devices.

Instructions for EUDAMED Bulk Upload

1. Download Template

Download the template template_eudamed_mdr_devices.xlsx from the EUDAMED XML Creator App.

2. Populate Template

Carefully populate the downloaded template according to the instructions in the template and the applicable EUDAMED business rules.

3. Upload and Validate Template

Upload the populated template via drag-and-drop to the EUDAMED XML Creator App. The app automatically creates a validation report. Download this to analyze and fix any errors. If validation is successful, an XML file will be generated that you can download.

Make sure to carefully check the validation report before uploading the XML file to EUDAMED. The XML Creator App performs basic validation, but EUDAMED may have additional validation rules that could lead to rejection of the upload.

4. Upload XML File to EUDAMED

Navigate to «Data Transfer» > «Bulk Upload» > «New Upload». Select the appropriate upload type under «Select a service»: «Upload of Legacy / Regulation Device / SPP (Basic UDI and UDI-DI / Master UDI-DI)». Upload the generated XML file at «Upload file in XML format». Click «Send».

5. Monitor Upload Status

On the confirmation page, click the «Go to Upload Management» link. Monitor the status of the upload on the upload management page. Refresh the page to see the current status.

Status «Failed»: Click the corresponding link in the «Response» column to download the validation report from EUDAMED. Read the errors, fix them, and repeat the process.

Status «Successful»: The data has been successfully uploaded to EUDAMED.

Upload Populated Excel File

Drag & Drop your file here or click to select

Browse Files

Download XML

Download validation report

BETA: The EUDAMED XML Creator App is a Stateless Web App. It does not permanently store any user data and does not share it with third parties. Only a temporary session for language selection is used. All uploaded Excel files and generated XML data are processed in memory only and are completely deleted when refreshing the page or closing the browser. The app does not use a database and does not store any information about medical devices.