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Provision of device data

If the certificate also includes devices, indicate whether the certificate is for a Custom made class III implantable, if yes provide a description, if no provide:

The name and the risk class, the reference/catalogue number and the risk class or the Basic UDI-DI (Basic UDI-DIs must be already submitted by the manufacturer in EUDAMED).

  1. In this step you may choose to provide a custom-made device by selecting Yes within Custom made class III implantable box:

    EUDAMED custom made risk class III implantable field and remove this device and add a device links

  2. By doing so, EUDAMED will allow you to provide a description for the custom-made device:

    EUDAMED custom made class III implantable field with yes option selected, description field and remove this device and add a device links

  3. When you select No, then the system will provide a dialog to select Name or Reference/Catalogue number options in order to register a device by its name, its reference/catalogue number or its basic UDI-DI:

    EUDAMED custom made class III implantable field with no option selected, description field and remove this device and add a device links

  4. When either Name or Reference/catalogue number is selected, you must provide the risk class of the device:

    EUDAMED custom made class III implantable field with no option selected and the fields enabled

  5. Click Save to save your draft or Save & Next to continue to the next step.