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Administrative information

  1. Click on the Administrative Information section from the menu on the left:

    EUDAMED MIR Administrative information section

  2. Choose the status of the MIR and provide the reference number assigned by the National Competent Authority in the field below:

    EUDAMED MIR Admin info section

  3. Provide all the relevant dates relating to the incident:

    EUDAMED MIR Admin info section with incident dates fields

    Note

    The Expected date of the next report refers to cases of a submission of a MIR in state Initial or Follow-up, otherwise it will not be visible to fill in.

  4. Select the classification of the incident:

    EUDAMED MIR Admin info section: classification of incident

  5. Provide the contact details of the report in the corresponding sections:

    EUDAMED MIR Contact info of the report

    Note

    Non-EU manufacturers must provide the Actor ID / SRN of the concerned Authorised Representative (regardless of the AR’s mandate status):

    EUDAMED MIR Authorised Representative Actor ID/SRN field

  6. If you wish to link this MIR to other MIRs, please provide the relevant references:

    EUDAMED MIR Reference to other Vigilance reports field

    Insert the Manufacturer’s reference number of the concerned report and select it from the list:

    EUDAMED MIR Manufacturer reference drop-down

    In case the report is not yet registered in EUDAMED, use the field for non-registered reports to type the manufacturer reference of the concerned report:

    EUDAMED MIR MF reference for non-registered report

    If applicable, provide additional reference to PSR reports or PMCF/PMPF investigations:

    EUDAMED MIR: Reference to PSR ID

    If the incident occurred within a PMCF/PMPF investigation, provide the EUDAMED ID of the relevant investigation:

    EUDAMED MIR: EUDAMED ID of relevant PMCF/PMPF investigation