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EUDAMED DI identification information

  1. Select the applicable legislation:

    EUDAMED applicable legislation in the legacy device registration page

  2. Select Yes or No to whether a UDI-DI is already assigned to the legacy device. If yes, enter the Issuing Entity and the UDI-DI code, and click Generate. EUDAMED will create a corresponding EUDAMED DI (the UDI-DI code with “B-“ as prefix).

    EUDAMED is it a kit and special device type fields in the basic udi-di main information page

  3. Non-EU manufacturers have to select the authorised representative (AR) for the current device from the options available.

    If there is only one AR with an active Mandate with the manufacturer, it will be automatically retrieved:

    EUDAMED authorised representative identification in the eudamed di identification information step

  4. Click on Save & Next to save it as a draft and continue with the following steps:

    EUDAMED save and next button

  5. On the left you will see a summary of the device characteristics.

    Choose a Risk class from the list and select Yes or No for each of the options.

    EUDAMED risk class field in the eudamed di identification step when registering legacy devices

  6. Select Yes or No if the device model is applicable and, if applicable, enter the Device model and enter a Device name if there is one, otherwise enter only a Device name:

    EUDAMED device model applicable, device model and name fields in the eudamed di identification information step

  7. Click on Save to save your draft and complete it later, or Save & Next to save it as a draft and continue with the following steps:

    EUDAMED save and save and next buttons