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  • 1.  QR code labelling

    This message was posted by a user wishing to remain anonymous
    Posted 29-Nov-2021 15:22
    This message was posted by a user wishing to remain anonymous

    HI all,

    We are looking at reducing our environmental footprint with our labelling of our IVD kits (IVDD and IVDR)

    We will have the UDI labelling of course, but is it possible to include any other info with QR codes. Such as:

    Residual risks etc
    Version of IFU that can be found online
    Product hazard labelling

    Thanks


  • 2.  RE: QR code labelling

    Posted 30-Nov-2021 04:04
    Hello,

    Some of that yes, like have a QR Code for an eIFU, but there is still basic information which would be needed on the product labelling.  Without knowing the specific product type or packaging configurations it would be hard to provide further information.  Immediate hazards are generally recognised as needing to be on the product labelling and there are many symbols which can be used now to convey other information.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: QR code labelling

    Posted 30-Nov-2021 04:45

    I assume your question is mostly coming from a practical point of view?

    It sounds like you want to have an eIFU (check the relevant guidance etc, not an expert) and to support this you will have a QR code to help direct users to this, probably as part of your website or as a smartphone app. 

    I would treat QR codes like translating information into another language, it just happens to be very compactly written and easily read by a smartphone. Some cleverer uses of QR codes require some dedicated software on the reading device, e.g. app on a smartphone.

    In your case, the QR code could be a web address for your eIFU, or a web address for a phone to open an eIFU app in the phone's app store (a web address in the right format will open in the app store, instead of a web browser).

    Given that residual risks and hazards must be included in an IFU, a second QR code could be a link that directs to that particular section on your webpage or eIFU App - specify this requirement before getting your webpage or app written.

    *Note on IEC 62366-1, you may need to document that your user groups will all be smartphone users and perhaps do some usability testing to ensure that they can access your eIFU. Can users also still request a paper copy of your IFU? (rhetorical) 



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    Chris Barkway
    Petersfield
    United Kingdom
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    Original Message


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