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UDI-DI identification information

vid-icon.jpg VIDEO: UDI carrier and display formats

VID_3_short___What_about_UDI_carriers.jpg

  1. Select the Issuing Entity from the drop-down list and enter the UDI-DI code.

    Important

    The UDI-DI code you enter must be unique. If it already exists in EUDAMED, you will not be able to Save.

    Exception: the same UDI-DI can be used for a Legacy Device and its Regulation Device equivalent.

    If the same UDI-DI code was already provided for a Legacy Device (i.e. Applicable Legislation MDD, AIMDD or IVDD), you will be prompted that a link will be created between the two devices (the Regulation and the Legacy Device) on the condition there is no conflict between some of the Basic UDI-DI properties and the related legacy device EUDAMED DI properties. In case of conflict, the system will prevent you from using the same UDI-DI.

    Note

    In the case of a GS1 Issuing Entity, the UDI-DI code you enter must be a 14-digit code including the check digit that will be used by EUDAMED to validate the UDI-DI code. If your GS1 UDI-DI (GTIN code) is less than 14 digits (check digit included), when populating EUDAMED field, please add leading zero(s) until you reach 14 digits.

    For example:

    000000nnnnnnnn (GTIN-8)

    00nnnnnnnnnnnn (GTIN-12)

    0nnnnnnnnnnnnn (GTIN-13)

  2. If applicable, enter the Secondary UDI-DI from a different Issuing Entity to the UDI-DI:

    EUDAMED secondary udi-di from a different issuing entity when registering a basic udi-di together with the first udi-di

  3. Enter the EMDN code and click on Find, and select the correct one from the list:

    EUDAMED emdn code field in udi-di identification information step when registering a basic udi-di together with the first udi-di

  4. If applicable, enter the trade name (as specified on the device label) and select its related language (select All languages if not language dependent):

    EUDAMED device trade name and language in the udi-di identification information when registering a basic udi-di together with the first udi-di

  5. Enter the Reference/Catalogue number:

    EUDAMED reference/catalogue number in the udi-di identification information step when registering a basic udi-di together with the first udi-di

  6. Specify whether the device is directly marked or not:

    • If the device is directly marked, you must either indicate it is the same as the UDI-DI or enter the UDI-DI and issuing entity of the Direct marking DI.

    EUDAMED is the device directly marked field in the udi-di identification information step when registering a basic udi-di together with the first udi-di

  7. If the device is not directly marked and the base quantity of the device is greater than one, you may enter the Unit of Use DI and its issuing entity:

    • The same Unit of Use DI can be used for different UDI-DIs in case the same device has different root packaging (each one having a different UDI-DI).

    EUDAMED quantity of the device, issuing entity and unit of use di fields when registering a basic udi-di together with the first udi-di

  8. If the base quantity is less than two, then no unit of use Di is provided:

    EUDAMED is the device directly marked, quantity of device and type of udi-pi fields when registering a basic udi-di together with the first udi-di

  9. Select the Type of UDI-PI:

    EUDAMED type of udi-pi when registering a basic udi-di together with the first udi-di

  10. Enter any additional information you think important to specify about the device, select the language in which the additional information is provided and enter a URL (web address) if you have one for additional information online:

    EUDAMED additional product description and language fields when registering a basic udi-di together with the first udi-di

  11. Specify the UDI-DI status in selecting whether it is On the EU market, Not intended for the EU market or No longer placed on the EU market and click on Save or Save & Next:

    EUDAMED udi-di status of the device when registering a basic udi-di together with the first udi-di