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  • 1.  Regarding new symbols proposals for MDR

    Posted 04-Jun-2018 12:07
    ​Hi,

     As we know that EU MDR  745/2017 is mandating the manufactures to inform users if the device is a medical device and if the device contains
    1. CMR
    2. Endocrine disrupting  substances
    3. Human Rigin
    4. Animal orgin
    And other new symbols required for packaging.

    My question is does the ISO 15223 standard would be released with the updated symbols which will satisfy the MDR requirements ?
    When we can expect this standard to be released.
    Is there an seperate discussion or Forum happening regarding the symbols related to MDR?

    Please advice

    ------------------------------
    Vadivelan Dharanisingh
    Product Regulatoy Lead
    Chennai
    India
    ------------------------------


  • 2.  RE: Regarding new symbols proposals for MDR

    Posted 04-Jun-2018 12:38
    ISO TC 210/WG03, committee on "Symbols and nomenclaute for medical devices", is responsible for ISO 15223-1. WG3 is meeting in November to discuss creation & adoption of symbols to meet the EU MDR requirements. As ISO 15223-1:2016 is not up for systematic review yet, there are discussions going on about working on amendment to the standard in order to address these new requirements sooner.

    ------------------------------
    Lena Cordie
    Victoria MN
    United States
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    Original Message


  • 3.  RE: Regarding new symbols proposals for MDR

    Posted 05-Jun-2018 07:00
    Thanks for the question Vadivelan as I was curious about the same thing myself.  And thank you Lena for providing some information, will have to watch closely what comes out of the WG3 to see if they issue an amendment or not because the requirement to include this notification on the device labelling would be greatly simplified with 1 symbol.

    ------------------------------
    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 4.  RE: Regarding new symbols proposals for MDR

    Posted 05-Jun-2018 11:50
    Edited by Vadivelan Dharanisingh 05-Jun-2018 11:51
    ​Hi,

    Thanks Lena Cordie & Richard Vincins for responding my queries.

    Please let us know if you have any updates in future- regarding my questions.


    ------------------------------
    Vadivelan Dharanisingh
    Product Regulatoy Lead

    ------------------------------

    Original Message


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