Regulatory Open Forum

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  • 1.  EN 14971:2012 Annex ZA

    Posted 27-Jul-2014 20:31
    Has the interpretation of EN 14971 Annex ZA been clarified. 

    Most importantly, Deviation 7:  ...shall not attribute any addition risk reduction to the information given to the user.

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    Russell Pizzuto
    PPRE Consulting
    Solon OH
    United States
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  • 2.  RE: EN 14971:2012 Annex ZA

    Posted 27-Jul-2014 23:41
    Russell,

    Please refer to http://www.regulatorydoctor.com/interpretation-and-application-of-annexes-z-in-en-iso-14971-2012/



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    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 3.  RE: EN 14971:2012 Annex ZA

    Posted 28-Jul-2014 01:11
    You can get a heads-up on what the Notified Bodies are doing with the Z-Annexes by reviewing this document (http://www.team-nb.org/documents/2014/NBRG_Final_WG%20RM%20Draft_Not_Yet_adopted_142506_2.pdf) and proactively communicating with your Notified Body.

    I hope this helps. 

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    John Beasley RAC
    Founder and Senior Consultant
    Medtech Review, LLC
    Henderson NV
    United States
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    Original Message