EUDAMED Production v2.22.0: What Manufacturers Need to Know
The European Commission has released EUDAMED Production version 2.22.0 (2026), introducing functional updates across several modules, including Actors, UDI/Devices, Certificates, DTX, and the Public Site. While no new regulatory obligations are introduced, several changes may directly affect how manufacturers register, maintain, and update data in EUDAMED.
Below is a structured overview of the most relevant changes for medical device manufacturers, based strictly on the official release notes.
Actor Module: Improved Data Traceability
EUDAMED now displays “Last data confirmation” dates per Actor version, including the version number and confirmation date for each data update .
What this means for manufacturers
Manufacturers can clearly track when Actor data was last confirmed, including historical confirmations.
This enhances transparency and traceability, particularly relevant during audits, inspections, or data reviews.
There is no change to data submission requirements, but greater visibility increases accountability for keeping Actor data up to date.
UDI/Devices Module: Versioning of EMDN Codes
A key update in version 2.22.0 is the introduction of versioning for European Medical Devices Nomenclature (EMDN) codes .
EUDAMED now:
Displays the evolution of EMDN codes, including status changes and effective dates.
Prevents selection of obsolete or discarded EMDN codes.
Notifies users when an EMDN code linked to a device has been discarded, split, or had its scope reduced, prompting an update.
Automatically versions the device once the correct EMDN code is updated.
These changes apply to both the Restricted Area and the Public Website.
What this means for manufacturers
Manufacturers must ensure that EMDN codes linked to registered devices remain valid.
Updates to EMDN codes may trigger mandatory device versioning in EUDAMED.
While Market Surveillance and Vigilance modules are not yet linked to EMDN versioning, this functionality is planned for future releases.
Certificates Module: More Transparency for Legacy Devices
Two notable changes affect the Certificates module:
During registration or update of Legacy Devices, the Notified Body status (expired, withdrawn, or suspended) is now displayed next to the Notified Body name .
Notified Bodies can now reference unregistered EU manufacturers or producers when creating:
Refused Certificates
Refused or Withdrawn Applications
(Non-EU workflows will follow in a future release.)
What this means for manufacturers
Manufacturers working with Legacy Devices gain clearer visibility on Notified Body status directly in EUDAMED.
EU manufacturers may be referenced in certificate-related workflows even if not fully registered, which can affect how refused or withdrawn applications appear in the system.
Non-EU manufacturers should note that this functionality does not yet apply to them.
DTX: Technical Changes Affecting Data Exchange
Several technical updates have been implemented in the DTX services , including:
New mandatory message identifiers in XML payloads:
messageID, conversationID, and correlationIDUse of correlationID to ensure:
Faster response times
No data drift during paginated queries
Limitation of one UDI-DI per Basic UDI-DI in the DEVICE.POST service
Introduction of a “Partially Successful” status for bulk uploads
Updated file path structure for XML attachments
What this means for manufacturers
Manufacturers using system-to-system integration must ensure their XML payloads comply with the updated structure.
Bulk upload processes may now return partial success, requiring additional review of submission results.
These changes do not alter regulatory requirements but may require IT or interface updates.
Public Site: Enhanced Transparency of EMDN and Reports
The Public Site reflects several of the same updates introduced in restricted areas :
Public visibility of EMDN code versioning
Improved presentation of Market Surveillance Summary Reports, including:
Renaming “Member State” to “Country”
Display of submission dates
Expanded country selection (including Iceland, Norway, Liechtenstein, Northern Ireland, and Türkiye)
What this means for manufacturers
Device-related information, including EMDN changes, becomes more transparent to external stakeholders.
Public visibility reinforces the importance of accurate and up-to-date device data in EUDAMED.
Final Takeaway for Manufacturers
EUDAMED Production v2.22.0 does not introduce new regulatory obligations, but it raises the operational bar for data accuracy, traceability, and maintenance.
Manufacturers should:
Monitor EMDN code validity for all registered devices
Ensure Actor and device data confirmations are current
Review DTX integrations for technical compliance
Be aware of increased public transparency around device and certificate data
The full release notes are published by the European Commission and apply as of EUDAMED Production version 2.22.0 (2026).
