The update tool prepares a PATCH: an XML request to change supported information on existing MDR UDI-DI. It uses current EUDAMED XML exports only, without Excel, CSV or saved form profiles.
Before you start
Download fresh exports of your registered articles. Search for the devices in EUDAMED, use Generate XML file and retrieve the files from Download Management. Export each relevant result page separately. The current workflow shows up to 50 articles per page; one file is not automatically the complete search result. Import the pages together or in batches. Resolve duplicate UDI-DI before proceeding.
Select articles, then changes
- Choose one BUDI group and mark the articles to update. Handle other groups separately.
- Tick only the sections to change. The seven options are trade names, additional description, website, EMDN codes, market status, critical warnings, and storage/handling conditions.
- Read the values before editing: they start from the first selected article. The completed value for a checked field replaces that field on every selected article. For example, replacing the warnings with one warning does not append it to each article’s existing list.
- Choose the trade-name action deliberately. Description can be added or edited, not deleted. Only supported status choices are offered.
- Review the before-and-after values for every article. Confirm your selection and values, then validate and download the XML. Only selected articles with actual changes are included.
Unchecked fields retain each article’s own imported values. Market countries/dates, packaging and original-manufacturer changes are outside this checklist. A replacement must still be appropriate for each device.
After creating the file
Upload through Update of UDI-DI / Master UDI-DI and check the EUDAMED response. The tool advances changed articles’ version numbers, but EUDAMED checks whether those versions are current. After success, obtain fresh exports before another update.