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  • 1.  CEN/TR 17223

    Posted 26-Nov-2017 15:27

    Does anyone know where I can get a draft this TR or know when it will be published? 

    Thanks

    CEN/TR 17223 - Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and InVitro Diagnostic Medical Devices Regulation



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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Aroa Biosurgery
    Auckland
    New Zealand
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  • 2.  RE: CEN/TR 17223

    Posted 26-Nov-2017 15:49

    For CEN documents start with https://standards.cen.eu/dyn/www/f?p=204:105:0:::::

     

    Enter the number of the document in the Standard Reference box.

     

    The description returned is FprCEN/TR 17223 (WI=JT003049)

    Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

     

    The status is Under Development and the Sales Point is blank.

     

    The Abstract/Scope says, "This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes."

     

    The technical committee appears to be CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical device

     

    Since it is not published one cannot obtain it.

     

    I find this interesting, since CEN has not published an EU version of 13485 for the regulations. EN ISO 13485:2016 covers the directives, not the regulations.

     

    I wonder if the new scheme is to publish technical reports instead of EU versions of ISO standards.



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: CEN/TR 17223

    Posted 26-Nov-2017 16:07
    I found it for sale here:  


    Sincerely,

    John Beasley, RAC (US)
    Founding Member and Senior Consultant
    MedTech Review, LLC
    www.medtechreview.com
    www.linkedin.com/in/medtechreview





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    Original Message


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