MDKU Data Model Validator
Upload your XML file and validate it against DIN SPEC 91509. Ensure your device data is compliant before submission.
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Native MDKU compliance, built in
meddevo eTD outputs MDKU-compliant data natively — no manual mapping or export scripts required.
What is MDKU?
MDKU e.V. is a German nonprofit association that maintains a standardized data model for structuring technical documentation content in the medical device industry.
Knowledge Topic
A template describing what information is required from a regulatory point of view — the structural blueprint for documentation.
Knowledge Unit
Created from a Knowledge Topic for a specific medical device, containing the actual device-specific information and data.
Hierarchical Structure
The data model organizes knowledge topics from general, higher-level categories down to very specific documentation elements.
The MDKU data model is defined in DIN SPEC 91509 and maintained by the MDKU e.V., an independent nonprofit association founded in 2021 by a community of medtech professionals. Meddevo is a founding member of the association. It provides a shared vocabulary and structure for regulatory documentation required under MDR Annex II and III. The data model is published free of charge and is not tied to any specific software vendor, authority, or industry association.