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  • 1.  Article 88 - Trend reporting

    This message was posted by a user wishing to remain anonymous
    Posted 09-Mar-2020 08:42
    This message was posted by a user wishing to remain anonymous

    Hi,

    How does one identify the non-serious / undesirable side effects and determine the threshold for trend reporting ?

    Thanks,


  • 2.  RE: Article 88 - Trend reporting

    Posted 10-Mar-2020 03:32
    Hi Anon,

    You should read the Guideline GHTF SG2 N54 and MEDDEV 2-12-1.
    They give you information on how to identify all the events that must be subjected to trend analysis.
    GHTF SG2 N54 Annex C provides useful information on how to find the Baseline and Threshold for the statistical analysis,.

    Hope that helps

    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
    ------------------------------

    Original Message


  • 3.  RE: Article 88 - Trend reporting

    Posted 10-Mar-2020 03:58
    Hi anonymous,
    the advice of Spyros and the documents he references are of great help and assistance on how to perform trend reporting, be aware that these documents are not aligned with the MDR and ​in the end compliance with MDR is the end-point.
    MDR provides a definition for incidents (64) which should be used in trend reporting.

    ------------------------------
    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 4.  RE: Article 88 - Trend reporting

    Posted 10-Mar-2020 04:04
    Peter is correct of course. Those documents are just for guidance. A good start to develop your own system.

    The most important is that the trend reporting is not only an obligation to the authorities. It is a very important tool for the safety of the patients and the safety of your company

    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
    ------------------------------

    Original Message


  • 5.  RE: Article 88 - Trend reporting

    Posted 10-Mar-2020 12:34
    Hi Anon,

    A useful source for ideas on possible device problems common to your type of device is the FDA's Total Product Life Cycle database. Type in your product code and you get a list of reported problems and the number of reports. You can drill down to see which device was associated with each problem. MHRA also has a database for alerts and recalls, but it requires a bit more effort to sort the results. 

    Cheers
    Karen

    ------------------------------
    Karen Long RAC
    Vancouver BC
    Canada
    ------------------------------

    Original Message


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