Introduction
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI).
The UDI-DI/Device module of EUDAMED is used for the manufacturers to provide their UDIs/Devices information and ensure its availability to everyone. Moreover, it is used to manage the registration of devices and systems and procedure packs (SPPs) across the EU/EEA.
It falls within the responsibilities of manufacturers (MFs) of devices and system and procedure pack producers (SPPPs) to ensure product registration in the UDI/Device Module. Authorised Representatives and Importers cannot register devices or SPPs. The devices to be registered are defined by Article 2 in MDR and IVDR. UDI-DI/Device module of EUDAMED is used for the manufacturers to provide information on the devices and the corresponding UDIs and to make it available to everyone.
Tip
For a wider understanding on how to use the platform visit the EUDAMED Information Centre. For information specific to UDIUDI, visit the UDI Helpdesk.
Note
This user guide outlines the registration of medical devices, IVD medical devices, SPPs, the device data, including the corresponding Basic UDI-DI and UDI-DI.
Economic Operators (EOs) must register their organisation in the Actor (ACT) module before they are given access to EUDAMED and become able to register their devices and SPPs in the UDI/Devices module. See the EOs User Guide. Devices and SPPs must be registered in the UDI/Devices module before they are placed on the union market (see Q&A on EUDAMED gradual roll out). Device registration does not involve any assessment, review or approval by a Competent Authority (CA). Some of the information in EUDAMED is publicly available for searching and viewing.
Warning
The requirements for device registration differ, depending on when the device is placed on the market and depending on which legislation it is compliant with (“regulation devices”, "legacy devices", "old devices" – see Q&A on EUDAMED gradual roll out).
In EUDAMED, device/SPP registration in the UDI/Devices module means registering a device/SPP at the level of the device identifier. Production identifiers are not required.
EUDAMED does not contain all constraints defined in the MDR/IVDR, guidance and good practices, and therefore, it is not because something is possible in EUDAMED that it is necessarily allowed.
VIDEO: What is a UDI?
INFOGRAPHIC: Basic UDI-DI/UDI-ID concept
