On 5 January 2026, the European Commission announced the production release of EUDAMED version 2.22.0, introducing mandatory system updates that enhance medical device registration and data management across the European Union. The update affects manufacturers, Notified Bodies, and other medical device stakeholders, with mandatory use of the four core EUDAMED modules beginning on 28 May 2026.
Details of the Update
The release of EUDAMED version 2.22.0 strengthens traceability, data accuracy, and usability across key modules, including actor registration, device identification (UDI), certificates, and public information access.
For actor registration, “Last data confirmation” dates are now displayed by version, improving transparency around data validation status for all registered actors.
For device registration, EMDN code versioning has been implemented, and obsolete EMDN codes have been removed from selection lists, ensuring that only current nomenclature is used.
Within the certificates module, Notified Bodies are now permitted to reference unregistered EU manufacturers or producers when issuing refused certificates or handling related applications, including legacy devices.
From a technical standpoint, XSD schema version 3.0.25 is now mandatory for all DTX service requests, reflecting updated technical documentation requirements.
Bulk upload functionality has been enhanced to allow partial success statuses, supported by new XML response structures that provide object-level feedback.
On the public site, usability improvements include expanded country options and enhanced summary report filters, improving public access to medical device information.
Enforcement Timeline
Mandatory use of the four core EUDAMED modules, actor registration, device identification (UDI), certificates, and public information access, takes effect on 28 May 2026.
Effective Date
Mandatory use of the four core EUDAMED modules, including actor registration, device identification (UDI), certificates, and public information access, takes effect on 28 May 2026. From this date, medical device manufacturers, Notified Bodies, and other relevant stakeholders must comply with the updated requirements introduced under EUDAMED version 2.22.0.
Why It Matters
These updates provide greater regulatory clarity, align EUDAMED more closely with digital data governance expectations, and improve operational efficiency through enhanced traceability and structured data exchanges. By refining workflows and technical standards, the update supports compliance while aiming to minimize unnecessary administrative burden for regulated stakeholders.
Who This Is Relevant For
This update is particularly relevant for Regulatory Affairs, Quality Assurance, IT and data management teams, and Notified Body operations involved in EU medical device registration, certification, and ongoing compliance monitoring.
Next Steps
Stakeholders should review existing data entry and device registration processes to ensure alignment with EUDAMED version 2.22.0, assess system compatibility with XSD schema version 3.0.25, and prepare for changes to EMDN code selection, confirmation date tracking, and bulk upload responses ahead of the May 2026 enforcement date.
As organizations assess readiness for mandatory EUDAMED module use and evolving data requirements, having early visibility into regulatory system changes can significantly reduce compliance risk. RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, helping teams track EUDAMED updates, assess impact, and streamline compliance preparation across more than 160 countries. Learn more or book a demo now.
FAQs
What is EUDAMED version 2.22.0?
EUDAMED version 2.22.0 is a production release that introduces mandatory updates to medical device data management, traceability, and technical interfaces within the EU.
When does mandatory use of the EUDAMED core modules begin?
Mandatory use of the four core EUDAMED modules begins on 28 May 2026.
What changes were made to EMDN codes in this update?
The update introduces EMDN code versioning and removes obsolete codes from device registration selections.
How can RegASK support companies responding to AI-driven regulatory changes?
RegASK helps organizations monitor regulatory authority updates, assess compliance impact, and adapt internal workflows through AI powered regulatory intelligence and expert guided automation.
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