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Basic UDI-DI identification information

vid-icon.jpg VIDEO: UDI and medical software devices

VID_3_LONG___UDI_and_software.jpg

  1. Click on Register a new Basic UDI-DI:

    EUDAMED register a new basic udi-di link in the dashboard

  2. On the next page, enter the Basic UDI-DI information. Select the applicable regulation.

    Note

    In this guide demonstration, the selection is MDR (Regulation (EU) 2017/745). Based on the regulation you choose, the characteristics of the Device to be entered will vary.

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

    Depending on the regulation that you have selected an additional question appears at the bottom of the page:

    Regulation

    Additional question

    MDR

    Is it a System or Procedure Pack which is a Device in itself?

    + additional sub-questions about the device type, depending on whether your answer is Yes or No to this first question

    IVDR

    Is it a kit?

    + additional sub-question about the device type, if you answer No to this first question

    EUDAMED basic udi-di identification information step when registering a basic udi-di together with the first udi-di

    If you select No, please choose the right information under the appearing section Special Device type (for IVDR, if you select No for Is it a Kit?, the only option for Special device type if applicable is Software[12] (See video on the top of the page):

    EUDAMED special device type in the basic udi-di identification information step when registering a basic udi-di together with the first udi-di

    Note

    As of now it is not possible to register devices with the following Special Device types:

    • Standard soft contact lenses

    • Rigid Gas Permeable (RGP) Contact Lenses

    • Made-to-order soft contact lenses

    • Spectacle frames

    • Spectacle lenses

    • Ready-made reading spectacles

  3. Fill in the Basic UDI-DI identification details and click on Save & Next:

    EUDAMED basic udi-di main information when registering the basic udi-di together with the first udi-di

    Important

    EUDAMED will validate the Basic UDI-DI code based on the specific format for each Issuing Entity and will prevent you from going further if the code is not valid.

    If the Basic UDI-DI code already exists in EUDAMED, the system will prevent you from saving, as a Basic UDI-DI must be unique.

  4. Non-EU Manufacturers will have to select the authorised representative for the Basic UDI-DI amongst those with which they have an active mandate registered in EUDAMED.

    If there is only one authorised representative with an active Mandate with the non-EU manufacturer, it will be automatically retrieved:

    EUDAMED details on the authorised representative identification when registering the basic udi-di together with the first udi-di

  5. Choose a Risk Class and select Yes or No for each option that follows.

    EUDAMED basic udi-di information risk class when registering a basic udi-di together with the first udi-di

  6. Select Yes or No if Device model is applicable. If the Device model is not applicable, the Device Name will be mandatory, otherwise, it is mandatory to enter the Device model and the Device name (at the Basic UDI-DI level) if there is one (note that the device trade name is part of the UDI-DI data):

    EUDAMED device model applicable toggle button and device model and name fields in the basic udi-di identification information step

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

    EUDAMED save and save and next buttons


[12] For more information, visit the EUDAMED Information Centre, or the UDI Assignment to Medical Device Software webpage.