Europe, 15 December 2025 — The European Commission has released an updated UDI Devices User Guide v 3.22.0 for the EUDAMED UDI/Devices module. This document serves as the definitive manual for manufacturers (MFs) and system/procedure pack producers (SPPPs) to ensure their product information is correctly registered and available to the public. This guide outlines the mandatory steps for registering Regulation Devices (MDR/IVDR) and highlights the strict dependencies between device registration and market access.
EUDAMED UDI/DEVICES USER GUIDE: CRITICAL REQUIREMENTS FOR MANUFACTURERS
The release of this guide reinforces several critical compliance triggers:
- Pre-Market Registration is Mandatory: Devices compliant with the MDR or IVDR (“Regulation Devices”) must be registered in the UDI/Devices module before they are placed on the Union market.
- Vigilance Blocking: Manufacturers cannot report serious incidents or submit vigilance reports in the EUDAMED Vigilance module unless the device involved is first registered in the UDI/Devices module.
- Public Visibility: Once a device registration is submitted (or confirmed by a Notified Body), much of the data becomes publicly available on the EUDAMED public website. Manufacturers must ensure data accuracy to avoid public-facing errors.
- User Roles: Access is restricted. A “Proposer” profile can draft records, but only a user with a “Confirmer” profile can officially submit device registrations to the system.
BASIC UDI-DI REQUIREMENTS: REGISTRATION SPECIFICS FOR UDI & DEVICE DATA
The guide clarifies the hierarchy and data requirements for different device types:
The UDI Hierarchy Manufacturers must register devices using a specific two-level hierarchy:
- Basic UDI-DI: The primary identifier for a device model group. This code connects devices with the same intended purpose, risk class, and design.
- UDI-DI: The specific unique identifier for the device itself. A device cannot be registered without both a Basic UDI-DI and a UDI-DI.
Legacy Device Linking If a manufacturer registers a new Regulation Device that has a direct equivalent “Legacy Device” (MDD/AIMDD/IVDD), EUDAMED will prompt a link between the two. This is critical for maintaining traceability across the regulatory transition.
Container Packages Registration extends beyond the device itself. Manufacturers must register the Container Package UDI-DI for every packaging level (e.g., cartons, cases) associated with the device.
MDR / IVDR Device Registration Resources
To ensure compliance, manufacturers should consult the following resources referenced in the guide:
- UDI Helpdesk: For specific questions regarding Unique Device Identifiers.
- EUDAMED Information Centre: For broader platform usage instructions.
Economic Operators Guide: For details on registering your organization and obtaining the correct user profiles (Proposer/Confirmer).