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  • 1.  Date of Manufacturing and Expiry Date symbol

    Posted 05-Jan-2023 16:15
    Edited by Shikha Malik 05-Jan-2023 16:15
    Hello all,

    Happy New Year!

    I am curious to know whether or not we need both Date of Manufacturing and Expiry Date symbol on the labels of a medical device (irrespective of the class). Or, any one of the symbols would suffice the requirement for ISO 15223-1 or EU MDR 2017/745. 

    If we need both, would it be possible to point me to the exact regulation? 

    Thanks!



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    Shikha Malik
    Sr. Regulatory Affairs Specialist
    Frisco TX
    United States
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  • 2.  RE: Date of Manufacturing and Expiry Date symbol

    Posted 05-Jan-2023 17:27
    Hello Shikha

    One or the other is required.
    If you wanted to show both, it isn't forbidden.

    See 2017/745, Annex I, points 23.2 (i) and (j).

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Date of Manufacturing and Expiry Date symbol

    This message was posted by a user wishing to remain anonymous
    Posted 11-Aug-2023 09:04
    This message was posted by a user wishing to remain anonymous

    Is that the same in the US that one or the other is required? 


    Original Message


  • 4.  RE: Date of Manufacturing and Expiry Date symbol

    This message was posted by a user wishing to remain anonymous
    Posted 14-Aug-2023 15:06
    This message was posted by a user wishing to remain anonymous

    No. It depends on the type of device, but some may not require either one in US.


    Original Message


  • 5.  RE: Date of Manufacturing and Expiry Date symbol

    Posted 06-Jan-2023 07:22

    This is a two-step process. The first question is to determine the date requirements in each regulatory region where you market your devices. The date requirements may differ.

    The second is to determine how to represent that the information is a date and which date. You need to know if the regulatory region allows symbols in place of text.

    ISO 15223-1:2021 provides the symbols. It does not have requirements for which symbols a manufacturer must have. That is a function of the regulatory region.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


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