Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce a device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.
The Commission is not in a position to require the use of the UDI/Device registration module until the transition periods laid down in Regulation (EU) 2024/1860 expire. Additional national requirements on registrations can therefore not be excluded.
Infographics
UDI/Devices Data sets
Overview of the MDR UDI and device data sets and IVDR UDI and device data sets to provide for their registration in EUDAMED
Documentation
- The EUDAMED Information Centre contains the relevant updated documentation including User Guides, technical documentation and Q&A sections
UDI Helpdesk
The UDI helpdesk provides support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, including UDI assignment, labelling and registration of devices.
This helpdesk also provides support as regards the use of the European Medical Devices Nomenclature (EMDN).
European Medical Device Nomenclature (EMDN)
The EMDN is the nomenclature to be used by manufacturers when registering their medical devices in EUDAMED.
The EMDN is fully available in the EUDAMED public site
For more information on the EMDN, see also the EMDN Q&A
Registration of legacy devices
Regulation (EU) 2024/1860 establishes the rules for the registration of legacy devices in EUDAMED.
You will find more information about legacy devices in the links below:
- MDCG 2019-5 - Registration of legacy devices in EUDAMED (revision ongoing)
- MDCG 2021-25 - Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC (revision ongoing)
- MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to legacy devices and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC (revision ongoing)
- Management of Legacy devices in EUDAMED - EUDAMED DI format
- Infographic – Legacy device identifiers
Guidance
Visit the Guidance page, particularly the Unique Device Identifier (UDI) and EUDAMED sections, for more guidance on the application of the relevant legislation.
