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Container package details

vid-icon.jpg VIDEO: UDI carrier placing

VID_2_short___Where_should_the_UDI_carrier_be_displayed.jpg

  1. Click on Add container package when there is a higher packaging level for the root UDI-DI:

    EUDAMED add container package link in the container package details step

    Each package level requires a unique UDI-DI assignment. You begin by registering the container package associated with the root UDI-DI (also known as the primary UDI-DI). You have the option to add multiple levels and container packages. Input the Issuing Entity, UDI-DI code for the package, Quantity per package, select the Package status and then click Save:

    Note

    If the UDI-DI already exists in EUDAMED, the system will prevent you from saving.

    EUDAMED add container package pop-up window in the container package details step

    Note

    If the status of the device for this container package is either No longer placed on the EU Market or Not intended for the EU Market, the Package status options are greyed out and any container package added to this device will automatically have the same Package status as the device.

  2. Select the generated information and click on Submit:

    EUDAMED container package list and submit button in the container package details

  3. A pop-up window will appear asking you to confirm your submission:

    EUDAMED pop-up window to confirm submission in the container package details step

  4. You will be redirected to a new page saying you successfully submitted your registration:

    EUDAMED basic udi-di registration submitted successfully message

    Important

    After submitting the Device, the state of the Device (Basic UDI-DI and UDI-DI) will be:

    • Registered, if the Basic UDI-DI data does not require a confirmation from the Notified Body (Basic UDI-DI and UDI-DI are publicly available in the EUDAMED public website);

    • Submitted, if the Basic UDI- DI data requires a confirmation from the Notified Body (Basic UDI-DI and UDI-DI are not publicly available and will only get the Registered state and become publicly available after Notified Body confirmation).