Regulatory Open Forum

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  • 1.  Notified Body requesting non-reportable changes in change files

    Posted 05-Jul-2016 19:49


    Question on behalf of a colleague: Does anyone's Notified Body request that you provide a list of non-reportable changes as part of the evaluation of a reportable change file?

     

     

     




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  • 2.  RE: Notified Body requesting non-reportable changes in change files

    Posted 06-Jul-2016 10:15
    That happened once to me. They wanted to see all changes to ensure themselves that all reportable changes had been recorded as such.
    Patrick






  • 3.  RE: Notified Body requesting non-reportable changes in change files

    Posted 06-Jul-2016 18:07

    I don't see how they could otherwise determine whether all reportable changes have, in fact, been reported.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 4.  RE: Notified Body requesting non-reportable changes in change files

    Posted 11-Jul-2016 13:18

    I would reach out to NB and reevaluate the threshold for reporting changes.  In some cases, reporting every single change is not feasible. 

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    Vishal Kanani RAC
    Sr Regulatory Affairs Specialist
    Intuitive Surgical Inc.
    Sunnyvale CA
    United States



  • 5.  RE: Notified Body requesting non-reportable changes in change files

    Posted 12-Jul-2016 12:26

    Hi Julia,

    Depends on your notified body; they may review your non-substantial changes which were not reported to them specially during your re-certification. Additionally in November 2014, the Notified Body Operating Group (NBOG) released their revised guidance on reporting of Design Changes & Changes of the Quality System. The interpretation of this guidance varies depending on the notified body. I recommend working with your NB to ensure compliance.

    http://www.nbog.eu/resources/NBOG_BPG_2014_3.pdf

    Thank you

    Shiven

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    [Shiven]
    [Regulatory Affairs]
    [San Francisco] [CA]