EUDAMED Data Management: Europe IT Consulting GmbH Uncovers Critical Error Sources in UDI Updates
The experts at Europe IT Consulting GmbH have identified a significant vulnerability in the EUDAMED architecture that makes data maintenance considerably more difficult for medical device companies. An improvement proposal submitted by the consulting firm (UR04419599) shows how technical dependencies between UDI-DI master data and market information can block both M2M interfaces and XML bulk uploads.
Inherent System Conflict: The “Catch-22” Logic
The issue arises when manufacturers want to update UDI-DI master data and make changes to the market information (Market Information) at the same time. Although a dedicated service now exists for market information, the system still requires market information data to be embedded when updating the UDI-DI (via the PATCH/PUT service).
This creates a technical contradiction that affects both automated M2M interfaces and manual XML bulk upload processes:
- Validation Stop: If the market information included in the UDI-DI block does not exactly match the current state stored in EUDAMED, the system refuses acceptance.
- Error Messages: Users receive the error ERR-BR-DTX-UDID-103.1 or are incorrectly instructed to use only the market information service.
- Sequencing Issues: In practice, this leads to a “race condition.” If market information is updated first, the snapshot in the UDI-DI update is outdated and gets rejected. If the UDI-DI is sent first, it must necessarily contain “old” data to be accepted—creating a logical paradox.
Europe IT Consulting GmbH Drives Improvements Forward
As a leading specialist for EUDAMED integrations, Europe IT Consulting GmbH has analyzed this process flaw and submitted an official change request to the European Commission. The goal is to drastically increase efficiency for manufacturers and reduce error rates in mass data uploads.
“This unnecessary dependency makes smooth automation and efficient bulk uploads nearly impossible,” explains a spokesperson for Europe IT Consulting GmbH. “We are advocating for these services to be decoupled in order to minimize the administrative burden for the industry.”
The Solution Path: Decoupling the Data Services
The consulting experts’ proposal recommends making the market information block in the UDI-DI update service optional or removing it entirely. This would:
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Significantly reduce susceptibility to errors in bulk uploads and M2M transmissions.
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Increase data consistency, since each service would be responsible only for its specific domain.
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Simplify processing logic for IT departments.
Current Status: Official Procedure Ongoing
The responsible authority (DG SANTE) is currently reviewing the case under reference number EUDAMEDMDR-42288. The support team is currently analyzing the XML payloads and test logs provided by Europe IT Consulting GmbH in order to develop a system-wide solution.
For companies in the MedTech sector, this initiative is an important signal: it shows that targeted professional expertise can bring about direct improvements to the European database infrastructure.
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