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  • 1.  STED Format for Notified Body Opinion Submission

    This message was posted by a user wishing to remain anonymous
    Posted 16-Feb-2022 09:45
    This message was posted by a user wishing to remain anonymous

    Hello, 
    Does anyone have experience with submitting data in STED format to a Notified Body to obtain a Notified Body Opinion? Are there any recommendations for the STED structure? 

    Many thanks in advance!


  • 2.  RE: STED Format for Notified Body Opinion Submission

    This message was posted by a user wishing to remain anonymous
    Posted 17-Feb-2022 16:01
    This message was posted by a user wishing to remain anonymous

    The three notified bodies i have worked with have each provided expectations of what template to use to submit the technical documentation. As such i would recommend you reach out to your NB and ask them what is acceptable.
    Original Message


  • 3.  RE: STED Format for Notified Body Opinion Submission

    Posted 21-Feb-2022 10:42
    If your Notified Body is BSI, they have a whitepaper that provides guidance.  I will say, I still would love to see an example of how it was done as I think the guidance document is still lacking however it might be a place to start.

    ------------------------------
    Julie Popp
    Monona WI
    United States
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    Original Message


  • 4.  RE: STED Format for Notified Body Opinion Submission

    Posted 22-Feb-2022 08:05
    Unless you NB gives you a preferred order and content, you can use what you want, but you'll need a robust Table of Contents, hyperlinks if possible...

    I used the order of documentation set out in Annex II of the MDR.  That "seemed" to work.   In olden days, I used STED, which is helpful if you will go to Asia - lift it into ASEAN STED with different EPs and country specific forms and Declarations.   


    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 5.  RE: STED Format for Notified Body Opinion Submission

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2022 11:49
    This message was posted by a user wishing to remain anonymous

    Thanks for your feedback. I discovered similar situations as you described. NBs provide guidances but these guidances are still lacking. Following the IMDRF guidance seems to be way to detailed for an NBOp submission. From the experiences you've made, were the STED formats you provided sufficient or did NBs miss anything in particular?
    Original Message


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