The UDI code must be registered in the European database EUDAMED (European Database on Medical Devices), namely in the UDI/DEV module, active voluntarily since 2021.

The registration process involves:

  • The registration of the manufacturer and the device in EUDAMED.
  • Uploading the UDI-DI and a complete set of device information (e.g. trade name, risk classification, dimensions, indications for use, etc.).
  • The possibility of updating information in the event of changes to the device that affect the UDI-DI.