EUDAMED
Description
EUDAMED improves transparency, traceability and coordination across the EU medical device ecosystem. Manufacturers, notified bodies and competent authorities use the platform to register devices, submit documentation, report issues and maintain regulatory compliance throughout the product lifecycle.
While organizations can enter information directly through the EUDAMED interface, structured content significantly improves efficiency and accuracy. Using component-based authoring, teams can generate XML files that support machine-to-machine submission. This reduces manual data entry, ensures consistency across all documentation and accelerates the creation of compliant technical files. Structured content also helps manufacturers maintain clear document version control, reuse content across multiple submissions and prepare faster for regulatory audits. This is especially important for companies managing large portfolios of devices or frequent updates.
Example use cases
- XML generation: Generate XML output for EUDAMED submission.
- Consistency: Ensure consistent terminology and data across all device files.
- Reuse: Reuse approved content across MDR and IVDR documentation sets.
- Automation: Reduce manual entry by enabling machine-to-machine data exchange.
- Traceability: Maintain traceability throughout the product lifecycle.
Key benefits
RWS perspective
RWS helps medical device manufacturers meet MDR and IVDR obligations with structured content solutions powered by Tridion. Component-based authoring, semantic tagging and controlled workflows provide accurate, reusable content that integrates smoothly with EUDAMED submission processes.