European Commission Publishes Updated EUDAMED UDI Devices User Guide
The European Commission has published version 2.27.0 of the EUDAMED User Guide – UDI Devices, providing updated operational guidance for manufacturers and System/Procedure Pack Producers (SPPPs) using the UDI/Devices module of EUDAMED.
The guide explains how manufacturers should register Basic UDI-DIs, UDI-DIs, device information, packaging hierarchies, and market data under MDR (EU) 2017/745 and IVDR (EU) 2017/746.
Registration Responsibilities Remain with Manufacturers
According to the guide, manufacturers and SPP producers remain responsible for device registration within the UDI/Devices module. Authorised Representatives and importers cannot register devices or SPPs on behalf of manufacturers.
The document also reiterates that:
Economic Operators must first register in the Actor module before accessing the UDI/Devices module;
Devices and SPPs must be registered before being placed on the EU market;
Device registration in EUDAMED does not constitute review or approval by Competent Authorities.
Attention to Data Accuracy
The updated guide highlights the importance of accurate data submission.
The Commission notes that certain fields cannot be edited after submission and that EUDAMED validates UDI codes based on format requirements only.
For manufacturers, this reinforces the importance of reviewing:
Basic UDI-DI assignments;
UDI-DI uniqueness;
EMDN code selection;
packaging configurations;
market status information.
The guide also clarifies that duplicate UDI-DIs are not accepted in EUDAMED, except in specific cases involving legacy devices and equivalent regulation devices from the same manufacturer.
EMDN Code Management
Several sections of the guide focus on EMDN code management and version history.
According to the document, if an EMDN code becomes inactive, split, or scope-reduced, EUDAMED may issue warnings and prompt manufacturers to update device records using revised nomenclature codes. In such cases, users may also receive EUDAMED and email notifications.
The guide additionally explains how users can:
search EMDN codes;
review nomenclature version history;
identify obsolete codes during device maintenance activities.
Packaging Hierarchies and Market Information
The Commission also provides detailed guidance on container package registration and maintenance.
The document confirms that each packaging level must have its own unique UDI-DI and that packaging status may automatically follow the status of the associated device.
Additional sections explain how manufacturers can:
update market information independently;
manage container package versions;
modify device availability status;
maintain historical versions of device records.
Legacy Device Linking and Version Control
The updated user guide also describes functionalities for linking MDR/IVDR regulation devices to registered legacy devices.
The document includes operational guidance on:
creating new record versions;
viewing historical versions;
updating Product Original Manufacturer information;
discarding incorrect registrations when necessary.
What This Means for Manufacturers
Although the document does not introduce new regulatory requirements, it provides additional operational clarification on how manufacturers are expected to manage device data within EUDAMED.
Manufacturers currently preparing MDR and IVDR submissions should review the updated guidance carefully, particularly regarding:
UDI assignment;
EMDN maintenance;
packaging structures;
market information updates;
lifecycle management of registered devices.
Read the full document below.
