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Device group and device

A device group or a device is mandatory to provide for Quality-type certificates.

  1. Click + Add a device group:

    EUDAMED add a device group and remove this device group links in the device groups sec

  2. Provide either a Name, Reference/Catalogue number or Basic UDI-DI. Note that these options also apply when registering a Refused/withdrawn application for a Quality-type certificate:

    EUDAMED provide one of the below field in the device group page

  3. Choose the Risk class:

    EUDAMED risk class field in the device group page

  4. Depending on the risk class, choose Yes or No whether the device is custom-made or not:

    EUDAMED custom made class III implantable field in the device section

  5. Click Save & Next.

  6. Add a device and its Basic UDI-DI by clicking + Add a device:

    EUDAMED add a device link and save, save and next and cancel buttons

  7. Provide either a Name, Reference/Catalogue number or Basic UDI-DI:

    EUDAMED provide one of the below field

    If you select the Basic UDI-DI, the Enter Basic UDI-DI code field is displayed.

    Enter the Basic UDI-DI code and click Check Registry:

    EUDAMED enter the basic udi-di code field, remove this device and add a device links and check registry, save, save and next and cancel buttons

    In the pop-up window either select the device from the list (if the device is already registered in EUDAMED) or click the Enter data manually button (if the device is not yet registered in EUDAMED) to add the Basic UDI-DI manually:

    EUDAMED list with registered basic udi-dis, pagination and next and close buttons
    EUDAMED informational message and enter data manually and cancel buttons

    After clicking on the Enter data manually button, a new screen appears. Provide the Issuing Agency and the risk class of the device:

    EUDAMED basic udi-di, issuing agency and risk class fields

    Specify if the device model is applicable or not:

    EUDAMED device model applicable, device model and name fields
    EUDAMED device model applicable and name fields

  8. Click Save & Next.