UDI/Devices Registration

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.

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 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

EUDAMED Medical Consultancy is always ready to help you manage EUDAMED UDI/DEvices Registration processes on behalf of your company.

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