EUDAMED UDI/Devices User Guide – Release 3.22: What Manufacturers Need to Know
The European Commission has published Release 3.22 of the EUDAMED UDI/Devices User Guide (December 2025), providing updated and detailed instructions on how manufacturers and system/procedure pack producers must register medical devices and IVDs in EUDAMED under the MDR and IVDR frameworks.
This user guide is a key operational document supporting compliance with Article 29 of the MDR and Article 26 of the IVDR, clarifying how device data, Basic UDI-DI and UDI-DI information must be structured, submitted and maintained throughout the device lifecycle.
Scope of the UDI/Devices Module
The UDI/Devices module is used exclusively by manufacturers and system/procedure pack producers to register:
Medical devices and IVDs compliant with MDR/IVDR (“regulation devices”);
Systems and Procedure Packs (SPPs);
Associated Basic UDI-DI, UDI-DI and container packaging levels.
Authorised Representatives and Importers cannot register devices in EUDAMED. However, manufacturers must ensure that all required Economic Operator (EO) registrations are completed in the Actor module before accessing the UDI/Devices module.
Key Functional Areas Covered in Release 3.22
Release 3.22 provides detailed, step-by-step guidance for several critical areas, including:
Registration of Basic UDI-DI and UDI-DI, including validation rules per issuing entity;
Mandatory use of EMDN codes, and how updates (including splits or discontinued codes) impact device records;
Differentiation between regulation devices, legacy devices, and old/custom-made devices, aligned with the EUDAMED gradual roll-out strategy;
Management of container packaging levels, with each level requiring a unique UDI-DI;
Device status options: on the EU market, not intended for the EU market, or no longer placed on the EU market;
Version control and historical traceability for registered device records.
The guide also reinforces that device registration in EUDAMED does not involve assessment or approval by Competent Authorities. However, inconsistent or incorrect data may introduce compliance risks in areas such as vigilance, market surveillance, and traceability.
Why This Matters for Manufacturers
While EUDAMED is still undergoing phased implementation, correct and timely registration in the UDI/Devices module is:
A regulatory obligation under MDR and IVDR;
A prerequisite for enabling vigilance reporting in EUDAMED;
Key to ensuring market transparency and device traceability across the EU/EEA.
Once device data is submitted, several fields become non-editable. Errors at registration may require discarding and re-submitting device records — a process that can impact compliance and product availability.
