Regulatory Open Forum

 View Only

  • 1.  Symbols in IFU Glossary but not on product labeling

    This message was posted by a user wishing to remain anonymous
    Posted 14-Jan-2022 13:48
    This message was posted by a user wishing to remain anonymous

    Hello All,

    Would a regulatory authority issue a nonconformance if the IFU symbols glossary contains symbols that are not on/in the labeling (packaging, labels, IFU, manuals, etc.)?

    Thank you!


  • 2.  RE: Symbols in IFU Glossary but not on product labeling

    Posted 15-Jan-2022 23:03
    If they are symbols that are needed to meet the regulatory requirements you are meeting or for your product specification that supports your risk management for labeling requirements I would say yes, then the national regulator may issue a non-conformance potentially.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 3.  RE: Symbols in IFU Glossary but not on product labeling

    Posted 16-Jan-2022 04:12
    Edited by Francesco Ambrosio 16-Jan-2022 04:12
    Absolutely agree with you @Leonard Eisner , the question is well described in the MDCG 2021-5 April 2021 :

    cit ( pag 6 ):

    "At the same time, it is worth noting that for medical devices there are "exceptions that proves the rule" when standards can be regarded as mandatory: it is the case of symbols and identification colours that "shall conform to the harmonised standards" when harmonised standards containing indications on symbols or colour coding are available (19). ​"


    Were the note 19  refers precisely to ISO 15223-1

    "For instance, the harmonised European standards EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03), and EN ISO 5359:2008 Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)+A1:2011."


    ------------------------------
    Francesco Ambrosio
    Ing.
    Italy
    ------------------------------

    Original Message


  • 4.  RE: Symbols in IFU Glossary but not on product labeling

    Posted 17-Jan-2022 01:55
    Hi Anon,

    despite the fact that you need to include all the symbols in your labeling that are required per regulations (risks, etc., as elaborated by Leonard and Francesco), I also want to strengthen the fact that it is very confusing to customers from a usability perspective to have symbols in a glossary and not on the labeling. Depending on the symbol this may lead to additional risks that you need to consider (e.g. having a warning symbol in your glossary that prevents a customer from using your product but that is not applicable for the product).

    All the Best

    Markus

    ------------------------------
    Markus Lantermann
    Head of Q&R Region International
    Mannheim
    Germany
    ------------------------------

    Original Message


Related Content