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Case A: General NCAR

  1. Select the General NCAR category in the first field:

    EUDAMED drop-down list with General category selection

  2. Select Yes or No in the Manufacturer field, as shown below:

    EUDAMED Yes or No to question: Is the Manufacturer registered in EUDAMED

    If you answered Yes to the previous question, you have to select the Actor ID/ SRN from the drop-down list in the field that will appear below:

    EUDAMED drop-down list for Actor ID/SRN selection

  3. Specify if the Manufacturer (MF) has an Authorised Representative (AR):

    EUDAMED Yes or No question: Does the MF has an AR?

  4. Specify if the NCAR is related to a Vigilance report:

    EUDAMED Yes or No question: Is the NCAR related to a Vigilance report?

    If Yes, provide the Vigilance item information below:

    EUDAMED Report type and Vigilance item reference in EUDAMED fields

  5. Specify if the NCAR is related to a device:

    EUDAMED Yes or No question: Is the NCAR related to a device?

    If Yes, provide the Device information below:

    EUDAMED Yes or No question: Is the device registered in EUDAMED UDI/Device Module
    EUDAMED UDI-DI Device reference type-in field

    If No, fill in the information in the appearing fields including Applicable legislation, Risk Class etc., as shown below:

    EUDAMED Applicable legislation, Risk Class, Device trade name, EMDN Nomenclature code, Device description fields.

  6. Provide any useful and relevant comments in the description fields under Additional information:

    EUDAMED Text fields for Comments, Background information, Conclusions, Recommendations

  7. Click on Browse under Related documents to attach any documents relevant to the information provided:

    EUDAMED Browse button for attachments

  8. Complete this section by ticking the impacted country(/-ies), the Competent Authorities of which will be notified about this NCAR:

    EUDAMED List of impacted countries for selection

  9. Submission:

    Submit the report by clicking on the blue Submit button on the top right corner:

    EUDAMED Submit button

  10. Finalise the submission of the report by clicking on Complete action in the pop-up window:

    EUDAMED Pop-up window with Complete action button and alternative Close button