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  • 1.  Non-significant notice of change to notified body

    Posted 14-Apr-2019 09:31
    Hi Fellows,
    I'd like to hear what is your experience with none-significant notice of changes to notified bodies. 
    In principle, the manufactures are not obligated to report non-significant changes but with the frequent technology changes often the manufacturers chose to notify the NBs just to be on the safe side (abundance of caution).

    1. Do you tell them in the NoC that this is non-significant change?
    2. Would you proceed to implement immediately without waiting for their response?
    3. Have you had push backs from NBs saying that you don't need to notify them about such changes?


    Thanks,
    Shimon


  • 2.  RE: Non-significant notice of change to notified body

    This message was posted by a user wishing to remain anonymous
    Posted 15-Apr-2019 17:16
    This message was posted by a user wishing to remain anonymous

    Hi Shimon,
    This really depends on the NB you are working with. I have seen it done in different ways with different NBs so there is no one-answer-fits-all.
    I would suggest to open this for discussion with your NB, put a list of representative changes that you have had or expect to have and ask whether they would like to see each of those changes and in what capacity. Take meeting minutes or share the slides so you have this documented.
    I have had one NB set up different types of Change Notices, where one type was for significant changes where we had to wait for approval and another type was for this scenario - where there was a change that we felt we wanted to share even though it was not significant and we didn't need to wait for their approval to implement. Also, sometimes they even confirmed that they agree with the classification of the change as non-significant and they don't feel the need to receive notification about this type of change again in the future.
    It is part of the NB's job to determine and advise what changes they consider significant and want to see and what is their process for that.


  • 3.  RE: Non-significant notice of change to notified body

    Posted 16-Apr-2019 09:01
    Edited by Shimon Vaknin 16-Apr-2019 09:01
    Thanks. Makes perfect sense. 

    Shimon