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  • 1.  Harmonized Standards

    Posted 10-Aug-2020 22:43
    If my device has been evaluated with all standards (IEC 60601-1: 2012 or IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012
    IEC 60601-1-6:2010 + A1:2013
    IEC 60601-1-8: 2006 (Second Edition) + A1: 2012
    IEC 60601-1-11:2015 (Second Edition)
    IEC 62304:2006 (First Edition) + A1:2015
    ISO 80601-2-69: 2014 (First Edition)
    EN 60601-1:2006+A11+A1+A12
    EN 60601-1-6:2010+A1
    EN 60601-1-8:2007+A1
    EN 60601-1-11:2015
    EN ISO 80601-2-69:2014
    EN 62304:2006+A1
    ANSI/AAMI ES60601-1:2005+A2(R2012) +A1
    CAN/CSA-C22.2 No. 60601-1:14
    CAN/CSA-C22.2 No. 60601-1-6:11 + A1
    CAN/CSA-C22.2 No. 60601-1-8-08 (R18)
    CAN/CSA-C22.2 No. 60601-1-11:15
    CAN/CSA-C22.2 No. 80601-2-69:16
    CAN/CSA-CEI/IEC 62304:1
    and My device is following the Directive 93/42/EEC. 
    and All the standards are harmonized 
    So I can use the CE mark on my device to sell in Europe and just have A declaration of conformity to the Directive 93/42/EEC. to register the device in Europe 
    Please Need some advice
    Thanks 

    ------------------------------
    YASSER ESTAFANOUS
    Director of RA/QA
    Winter Haven FL
    United States
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  • 2.  RE: Harmonized Standards

    Posted 24-Aug-2020 14:13
    Hi Yaseer,

    To sell in Europe the device must undergo a conformity assessment from a MDD designated notified body (for Class IIa, IIb and III devices). QMS audit requirements will also apply.
    From the standards you listed above, seems like it is an active device and has a software as well. DoC to 93/42/EEC will be needed, however, you do want to ensure that you get a CE certificate for the device as well from a notified body before you start selling in Europe. (Notified body assessment will not apply if it is a class I device).

    As MDR compliance date is quickly approaching - You would also want to check till when the notified bodies are accepting applications under MDD.

    I hope this helps.

    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
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    Original Message