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    UDI Notified Bodies

    Every medical device sold in Europe will require a valid approval certificate in accordance with MDR and IVDR. This certification is carried out by a notified body. This notified body must be assigned to the respective certificate. The notified bodies can be stored as master data.

    The UDI Notified Bodies page is accessed using Tell Me. Choose the Lightbulb that opens the Tell Me feature icon, enter UDI Notified Bodies, and then choose the related link.

    UDI Notified Bodies

    Field Description
    Code Specifies a notified body code that you can select.
    Description Specifies a text to describe the notified body.
    Contact No. Specifies the number of the contact that provides further data such as the address.
    CE Ident No. Specifies the four-digit identification number required for printing CE marks for basic UDI-DI data.

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