Data Version Management in EUDAMED

Understanding the Complexity Behind Data Modifications in EUDAMED

Restrictive modification rules

EUDAMED is a regulatory database with its own rules that are binding on all manufacturers who wish to distribute their medical devices in European Union countries.

Compared to the requirements of a purchasing group (GPO) on a manufacturer’s catalog data, little data in EUDAMED is modifiable, and when it is, these changes are tracked.

Thus, modifying data in EUDAMED often results in the creation of a new UDI-DI and, for modifiable data, an increment in the data version for the UDI-DI concerned.

It is therefore important to keep a few simple rules in mind:

Modifications prohibited in EUDAMED once device data has been published:

• Most attributes become non-modifiable after publication. They are considered ‘triggers’ in the sense that they lead to the creation of a new UDI-DI (or, in case of errors, the deletion of the existing record).
• Physical deletion of a record (“delete”) is only possible in “draft” status, i.e., before publication.
• Logical deletion of a record (“discard”) is only manual and possible if the device is not involved in a vigilance action.

Traceability of data authorized for modification

•  The value of certain attributes can be modified. These attributes are not considered ‘triggers’. However, such modifications do result in a new version of the record in EUDAMED history.

Some exceptions to the versioning of modifications:

• Adding EU countries
• Status in EUDAMED: Draft → Submitted → Registered (Published) → Discarded

Impact on Business Processes

Mandatory planning

Any significant change to the product, or to an attribute marked as a ‘trigger’ in EUDAMED, will lead to the generation of a new UDI-DI and the submission of a new record.

This requires:

• Publication of quality data
• Data validation prior to publication
• EUDAMED training for teams responsible for managing, collecting, validating, and publishing data

Complex error management

• Correcting non-modifiable data can only be done by manually deleting the record (Discard).
• Updates to modifiable data are versioned.

System coordination requirements

Effective coordination between EUDAMED and your internal information system requires:

– Synchronization of historical data between EUDAMED and your internal systems
– Implementation of version control within your regulatory product repository
– Full alignment between the records and data changes made in EUDAMED and those reflected in your internal traceability system

Understanding the Status of Records in EUDAMED

“Draft” status

• Data can be freely modified
• Can be completely deleted
• Not visible in public EUDAMED
• Recommendation: Correct data before publication

“Registered” status

• Official compliance status
• Data visible in EUDAMED
• Modifications limited to certain attributes
• New versions automatically created by EUDAMED when attributes change
• Logical deletion possible under “discarded” conditions

Note: The intermediate “submitted” status applies to devices requiring EU certification. Modifications are locked under this status.

“Discarded” status

• Maintained in EUDAMED history
• Not visible in public searches

EUDAMED Triggers

Many attributes in EUDAMED cannot be modified once published. Changing them can trigger a new UDI-DI and require relabeling of devices already produced.

Examples of triggers related to Basic UDI-DI:

• Change of notified body → FLD-UDID-01 “Issuing entity Basic UDI-DI”
• Change of legal manufacturer → FLD-UDID-10 “Legal Manufacturer SRN”
• Change of risk class → FLD-UDID-16 “Risk class”

Examples of triggers related to UDI-DI:

• Change in base quantity → FLD-UDID-151 “Quantity of device”
• Change in commercial reference → FLD-UDID-163 “Reference/Catalog number”
• Change in clinical dimensions → FLD-UDID-146 “Clinical Sizes”

Version Management Strategies

Principle 1: Upstream validation

Enhanced validation process:

• Technical validation: data compliance
• Business validation: consistency with technical documentation
• Regulatory validation: alignment with certificates and declarations
• Quality validation: comprehensive ALCOA+ checks

Support tools:

• Pre-publication validation checklist
• Data simulation in test environment
• Cross-validation by multiple users
• Automatic checks before submission

Principle 2: Planning changes

Anticipate modifications:

• Schedule product changes
• Integrate MDR/IVDR triggers
• Coordinate with certification cycles
• Plan regulatory updates
• Synchronize with EUDAMED changes

Principle 3: History and traceability

Ensure documentation:

• Justify each version creation
• Link to product modifications
• Maintain traceability with technical documentation
• Archive previous versions

Maintain history:

• Retain all versions internally
• Map EUDAMED versions to internal references
• Maintain certificate traceability

Tools and Processes to Control Versioning

Expected features

• Automatic change tracking
• Validation workflow before publication
• Change simulation in test environment

Recommended architecture

• Central regulatory repository
• Automatic synchronization (M2M)
• Bidirectional EUDAMED synchronization

Business Impacts

Direct costs

• Time spent re-entering data
• Resources for manual management
• Product launch delays
• Process complexity

Indirect costs

• Risk of non-compliance
• Confusion between active versions
• Audit traceability issues
• Impact on relations with authorities

Optimization and Best Practices

Optimization of changes

• Plan updates carefully
• Validate data before publication
• Coordinate updates with product cycles

Efficiency improvement

• Control costs via M2M automation
• Standardize modification workflows

Conclusion

Version management in EUDAMED is not just a technical constraint; it is a strategic pillar of compliance.

Keys to success:

• Anticipation: validate data before publication
• Organization: clear processes and defined roles
• Automation: M2M publishing tools for EUDAMED
• Training: educate teams on EUDAMED specifics

Companies that master versioning ensure compliance, streamline processes, and demonstrate adaptability.

ACKOMAS: Expert Control of EUDAMED

The ACKOMAS platform natively integrates efficient change management in EUDAMED.

With its automated workflows, validation controls, and full traceability, ACKOMAS transforms versioning complexity into a smooth, secure process.

📘 Download the complete EUDAMED guide