New Version of the EUDAMED User Guide for Devices with UDI - An Essential Resource for Manufacturers
The European Commission has published the latest version of the EUDAMED User Guide - UDI Devices, a technical document that aims to support manufacturers in submitting and managing information relating to medical devices and in vitro diagnostic medical devices (IVDs) under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).
This guide details the operation of EUDAMED's UDI/Device module, providing step-by-step instructions for registering, updating and consulting data on devices, systems and sets of procedures. The information provided is essential to ensure regulatory compliance, traceability and transparency in the European Union market.
Main aspects covered in the guide:
EUDAMED access requirements: from creating the EU Login account to assigning user profiles (Viewer, Proposer, Confirmer), with validation by the actor's administrator (LAA/LUA).
Registration of regulated devices (Regulation Devices): including the creation of new Basic UDI-DI and UDI-DI registrations, filling in technical information, device characteristics, certification information, packaging data and risk designations.
Management of system or procedure packs (SPP): with specific instructions for producers of sets of medical devices that are presented as a system or procedure pack.
Management of devices already registered: updating versions, change history, association with legacy devices, editing market information, original manufacturer, and discarding incorrect registrations.
Search and export functions: tools for consulting historical versions and for downloading structured data in XML format, useful for integration with internal systems.
Important notes:
The system automatically validates UDI codes and prevents the registration of duplicates or invalid formats, according to the issuing entity (e.g. GS1, HIBCC).
Some operations, such as submitting additional UDI-DIs, are only available when the corresponding Basic UDI-DI is in a valid registration state ("Submitted" or "Registered").
Non-EU manufacturers must select an Authorized Representative previously registered with EUDAMED.
The new version of the guide thus consolidates EUDAMED's role as the central digital infrastructure in the European regulatory framework, promoting a more transparent and standardized process for submitting and managing medical device data.
For manufacturers, this document is an essential reference tool, indispensable for implementing internal processes to comply with the requirements for registering and maintaining devices with EUDAMED.
Access the full document below.
