Data Version Management in EUDAMED
Data version management in EUDAMED is a critical issue that is often poorly understood by medical device manufacturers. Unlike a traditional database, EUDAMED is based on strict traceability, in which certain data is considered immutable…
Understanding the Complexity Behind Data Modifications in EUDAMED
Restrictive modification rules
- Most attributes become non-modifiable after publication…
- Physical deletion possible only in “draft” state…
- Logical deletion allowed only if not under vigilance…
Traceability of data authorized for modification
Some attributes can be changed; modifications create a new version in history.
Exceptions
- Adding EU countries
- Status change Draft → Submitted → Registered → Discarded
Impact on Business Processes
- Mandatory planning: validate data before publication
- Complex error management: non-modifiable attributes must be discarded
- System coordination: align internal and EUDAMED records
Understanding Record Status
Draft
- Freely editable
- Deletable
- Not visible in public EUDAMED
Registered
- Official compliance status
- Limited modifiable attributes
- Triggers version creation
Discarded
- Maintained in EUDAMED history
- Invisible in public interface
EUDAMED Triggers
Examples (Basic UDI-DI)
- Change of notified body
- Change of manufacturer SRN
- Change of risk class
Examples (UDI-DI)
- Change in base quantity
- Change in commercial reference
- Change in clinical dimensions
Version Management Strategies
- Upstream validation
- Planned changes
- Version traceability
Tools and Processes
- Automatic change tracking
- Bidirectional synchronization
- Central regulatory repository
Business Impacts
- Direct costs: manual rework, launch delays
- Indirect costs: audit risk, confusion, compliance loss
Optimization and Best Practices
- Plan and validate before publishing
- Automate versioning with M2M tools
Conclusion
Version management in EUDAMED is not just a technical constraint; it is a strategic advantage if well managed.
- Anticipation
- Organization
- Automation
- Training
ACKOMAS: Expert Control of EUDAMED
The ACKOMAS platform natively integrates efficient change management in EUDAMED.
With automated workflows, validation controls, and complete traceability, ACKOMAS turns versioning complexity into a reliable, transparent process.