Regulatory Open Forum

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  • 1.  Complaint investigation

    Posted 23-Oct-2018 06:31


    I refer to a previous discussion on this group for this topic.

    Dan had commented

    "In the warranty period, the report is a valid compliant and needs investigation; there

    are a number of Warning Letters to that effect. In the expected life period (after

    warranty), it is probably a valid complaint and may or may not require an investigation."


    Needed some clarification around this. After the warranty period but during the expected(service)life , what could be the rationale for not investigating a complaint ? When there is no requirement of  investigating complaints after the expected life , can this expected life be the service life ?


    Thanks & Regards,


    Rashmi Pillay
    Regulatory Affairs Associate


    3-4 Second Avenue

    Mawson Lakes SA, 5095


    T + 61 8 7074 8105


    One Powerful Vision.

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  • 2.  RE: Complaint investigation

    Posted 24-Oct-2018 07:34
    Hi Rashmi

    I would say: there is NEVER an excuse for not investigating a complaint. The warranty period has nothing to do with this. 
    You investigate complaints for two reasons: to ascertain if you need to inform any Competent Autorities and to learn something which can be utilized in your Clinical Evaluation or Design and Development of the device (or similar devices). 
    I know that complaints are tedious and time consuming, but they may give you a valuable new knowledge. 
    And in the same time they are an inevitable part of your PMS.

    Best regards

    Dorthe Wallin
    Regulatory Compliance Officer
    Cortex Technology

  • 3.  RE: Complaint investigation

    Posted 24-Oct-2018 09:32
    Agree with Dorthe.

    You must always investigate but you can decide to not report based on MDR/Vigilance regulations. Warranty period is time period set by a manufacturer which affects servicing and replacements, has nothing to do with the decision to investigate. A manufacturer must investigate a complaint even if the device is no longer sold.

    Vidyalakshmi Jayaraman
    RA Specialist
    Marlborough MA
    United States

  • 4.  RE: Complaint investigation

    This message was posted by a user wishing to remain anonymous
    Posted 25-Oct-2018 08:41
    This message was posted by a user wishing to remain anonymous

    I think people get confused between "complaint investigation" which is required by the regulations, and a failure investigation/CAPA which is not.