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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.

    Start by registering the container package associated with the root UDI-DI (also known as the primary UDI-DI). You may 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:

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

    Note

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

    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.

    Note

    When registering a Master UDI-DI code, a specific format validation algorithm is applied when the issuing entity is GS1:

    • For Standard soft contact lenses and Standard Rigid Gas Permeable (RGP) contact lenses the system applies the GMN format validation algorithm.

    • For Made-to-order soft contact lenses and Made-to-order Rigid Gas Permeable (RGP) contact lenses the system applies the GTIN format validation algorithm.

  2. Select the generated information and click on Submit:

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

  3. Confirm your submission in the pop-up window:

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

  4. The screen will display a success message:

    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 confirmation from the Notified Body (Basic UDI-DI and UDI-DI is publicly available in the EUDAMED public website);

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