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  • 1.  Is inner bag label required for medical devices?

    Posted 01-May-2023 14:24

    Hello,

    A question on inner label - when a medical device is packaged in an immediate packaging (primary packaging) and outer packaging intended to remain together, is it required to label the inner bag? The outer label is being affixed with all medical device requirements including the symbols. I went through the FDA and EU regulations but could not find anything specific to labeling the inner bag.

    I would appreciate if members can share their experiences on why or why not there should be an inner label. If inner label is required, what details ought to go on that label? 



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    Ajit Basrur
    Worcester MA
    United States
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  • 2.  RE: Is inner bag label required for medical devices?

    Posted 02-May-2023 04:02

    Hi,

    In brief: I would answer this question for each product separately based on usability / risk management considerations:
    Example one: a outer package contains 12 single packed products >> here I consider it foreseeable that a user unpacks the single products and stores these in a drawer, a shelf, >> likely that same labeling on the single product is approbriate. 
    Example two: a single product in a bag, placed in an single outer package which provides secondary protection and a box shaped housing for storage. >> here labeling on the inner bag might not ad "value". 

    @all >>  thoughts, did I miss a point?



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    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
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    Original Message


  • 3.  RE: Is inner bag label required for medical devices?

    Posted 02-May-2023 04:24

    Hello Ajit,

    It really depends on how the inner bag would be managed by the end user.  As an example, some products are double-bagged and sterilised to be used for introduction into the operating theatre where the outer bag is removed, passed in, and then at use the inner bag is removed.  In most cases, the inner bag would not need to be labelled because the product would "stay together" through the use of the product.  In fact, the latest version of ISO 15223-1 includes symbols for single/double bagged sterility configurations.  In non-sterile packaging, again it really depends on how the product and packaging is managed by the end-user.  As an example, a carton box would have all of the product identification, then an internal bag with 10 units inside, may not have a label on the bag itself.  Again it depends on how the packaging is taken apart and managed.  The best approach is always to document your reason and justification for an approach which is taken.  If there is a well-thought out and valid perspective, then documenting this justification and/or rationale makes it a bit more difficult for an external reviewer to challenge.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Is inner bag label required for medical devices?

    Posted 16-May-2023 11:32

    Hi Ajit,
    Consider the following points when determining whether to label the inner bag:

    1. Accessibility: Evaluate whether the information on the outer packaging label remains easily accessible and visible when the inner bag is opened or partially removed. Users should be able to readily identify and refer to the relevant labeling information without any ambiguity or confusion.

    2. Legibility: Ensure that the labeling information on the outer packaging is legible and can be read without difficulty. If the inner bag or immediate packaging obscures or compromises the legibility of the labeling content, it may be necessary to provide additional labeling on the inner bag to ensure clarity.

    3. User comprehension: Consider the potential impact on user comprehension and understanding of the device's instructions for use and safety information. If the labeling on the outer packaging alone is insufficient for users to comprehend the necessary information, additional labeling on the inner bag may be warranted.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
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    Original Message


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