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  • 1.  eIFU - label description China / EU

    Posted 21-Jul-2022 10:45
    Dear all,

    maybe someone can help me. 

    It is about the following:
    Usually symbols on labels (on packaging) are defined / explained in the IFU for medical devices.
    In case of eIFUs such symbols on packaging labels will not be explained at all when focusing on accompanied documents to the product delivered to the customers.
    Is it essential to provide information to the product regarding symbol explanations regardless of the fact that the eIFU content will provide all required information? 
    The question arised as it is in general not "user-friendly" if the manufcaturer just refers to the eIFU but symbols on the labels (on the packaging) are not defined.
    If the symbols on labels need to be explained anyhow, how could it be solved? 

    FYI: Only standard symbols of ISO 15223-1 are used.


    In focus of my request is the EU and Chinese market but also global requirements (Canada, USA, Brazil, Australia, ...) are of interest.


    Thank you very much in advance!

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    Anja Abelmann
    Göttingen
    Germany
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  • 2.  RE: eIFU - label description China / EU

    Posted 22-Jul-2022 02:22
    Hello Anja

    Thank you for your question.  

    As you mentioned, it is a common practice to explain symbols used on the device packaging in the IFU. Per regulation, the content of an eIFU must be identical to the content of the paper IFU. So if the device is eligible for eIFU, the explanation of the symbols can also be provided in the eIFU. This is of course the regulatory and compliance perspective.

    The eIFU allows the device user to access the symbol glossary without breaking the product seal, thereby allowing better preparation for the application of the device and the understanding of the symbols. User-friendliness in this regard is mainly determined by the usability of the eIFU system and the eIFU website.

    Most of our customers provide a symbol glossary on their eIFU webpage. Some of them do this in addition to the glossary in the eIFU but some use it as the central point of access to the symbol explanations. This allows the manufacturer to maintain their symbol explanations in one location instead of several IFU contents. Symbols in the glossary are explained in the language of the intended user, which is most relevant for the EU.

    The above is mainly for the EU, Canada, USA, Brazil, and Australia.  For China, the sinograms and the regulatory environment are challenging. It will be interesting to see other responses to your question.

    Best regards,

    Hans


     


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    Hans Strobel
    www.dokspot.io
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    Original Message


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