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Provision of certificate details

  1. Select the correct options:

    EUDAMED fields in the certificate details section

    Note

    When you have defined the scope of the certificate with a device group and/or device having risk class I that has the property Placed on the market in sterile condition, then the system will set Yes for the Devices in sterile condition question within the Special Device Type within the scope.

  2. Enter the conditions and limitations if there are any. If none, toggle to No:

    EUDAMED conditions and limitations with toggle button field and select the language of the certificate field

  3. Select the languages in which the electronic version of the certificate is issued. You may upload more than one electronic document if it covers different languages, and you may upload several documents at once.

  4. Click on either Save or Save & Next.