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  • 1.  EN ISO 13485:2016 Published in the Official Journal

    Posted 18-Nov-2017 12:12
    Hi All,

    On Friday the latest update published in the official journal included the replacement of EN ISO 13485:2012 with EN ISO 13485:2016. This is great news and will help everyone in the medical device industry moving forward with this third edition of the Quality Management System standard.

    Here is the notification (see items 2, 3 & 4):

    http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2017:389:TOC

    While I know that there are some improvements to be made, please also see the ISO published handbook for ISO 13485 available through AAMI here:
    ISO 13485:2016 Handbook (PDF)

    Aami remove preview
    ISO 13485:2016 Handbook (PDF)
    View this on Aami >





    ------------------------------
    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
    Regulatory and Quality Solutions
    Becker MN
    United States
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  • 2.  RE: EN ISO 13485:2016 Published in the Official Journal

    Posted 18-Nov-2017 16:10

    Thank you Mark for the information.

     

    To complete the picture there is other useful information worth noting.

     

    The ISO/TC 210/WG 1 Transition Planning Guidance for ISO 13485:2016 recommends that three years after publication by ISO of ISO 13485:2016, any existing certification issued to ISO 13485:2003 will not be valid.

     

    Since the publication date is March 1, 2016, the end of the validity period would be March 1, 2019. (Some references say February 28, 2019.)

     

    Health Canada has set January 1, 2019 as the deadline to obtain an MDSAP certificate. Most companies seem to be planning for an MDSAP certificate to the 2106 version.

     

    For the EU, the date of cessation of presumption of conformity of the superseded standard, EN ISO 13485:2012, is March 31, 2019.

     

    In planning, for the transition, there are three significant dates:

    Jan. 1, 2019 for MDSAP for Canada

    Mar. 1, 2019 for general certificates

    Mar. 31, 2019 for MDD presumption of conformity

     



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: EN ISO 13485:2016 Published in the Official Journal

    Posted 19-Nov-2017 02:47
    Thx to Mark and Dan for their info about ISO 13485:2016.  Good info to be aware and if you haven't started planning for the dates mentioned in Dan's comment I would get on it, as there are so many changes between MDR, MDSAP, ISO 13485, and also many device standards (such as IEC 60601-1 and many of the collaterals [IEC 60601-1-XX] are in process of being updated - planned publication around Dec 2019).

    Thx,

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


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