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  • 1.  Medical Device Labeling Standards

    Posted 30-Jun-2021 13:09
    Good day, Team

    We are a medical device company that functions as an initial importer, contract manufacturer, and manufacturer. We operate in multiple jurisdictions.  For this exercise assume the jurisdictions include MDSAP participating countries, EU and UK.

    What is the preferred standard for label management similar companies use for labeling?

    Thanks.


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    Patty Beja
    Manager, Regulatory Affairs
    Port Washington NY
    United States[
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  • 2.  RE: Medical Device Labeling Standards

    Posted 01-Jul-2021 01:51
    Hello Patty,

    What do you mean by label management?  This could be a number of things from content of labelling, generating the label structure, on-demand printing of labelling, storage of labelling prior to use, or the actual packaging and labelling process.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Medical Device Labeling Standards

    Posted 01-Jul-2021 06:45
    Good day-

    Mostly we are discussing content of labelling, generating the label structure, and the actual packaging and labelling process.

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    Patty Beja
    Manager, Regulatory Affairs
    Port Washington NY
    United States[
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    Original Message


  • 4.  RE: Medical Device Labeling Standards

    Posted 01-Jul-2021 14:41
    Edited by Patrik Brehm 01-Jul-2021 14:41
    Hello Patty,

    What a timely question! :)

    In terms of symbols, the new version of the ISO 15223-1 is scheduled to be released soon: https://www.iso.org/standard/77326.html

    For content, refer to MDR CHAPTER III, REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE, 23. Label and instructions for use.

    Do you have any other specific questions that you need help with?

    Best regards,
    Patrik

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    Patrik Brehm
    Senior Manager Quality Strategy
    Veeva MedTech
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  • 5.  RE: Medical Device Labeling Standards

    Posted 02-Jul-2021 01:49
    Thanks for the clarification Patty.  There are no labelling standards existing; as for content you would need to refer back to the individual regulatory requirements, i.e. 21 CFR 801, Annex I Section 23.  For the labels themselves there is no standard for content or methods of packaging/labelling positioning, placement, etc., except for ancillary standards like ISO 15223 for symbols and bar coding standards for UDI.  For content of instructions for use there is guidance out there like the FDA's Write it Right or the ISO 20417 standard recently published.  To me, I still find it surprising there are not more standardised labelling requirements for countries like the FDA and EMA have for medicinal products.  However, with the variety of different medical devices this might be challenging.  What I would recommend is an internal procedure for label generation, addressing all those points you raise, for how your company handles those activities.  This way there is a risk-based approach, standard method for your company, and how you address labelling which is specific to your product.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 6.  RE: Medical Device Labeling Standards

    This message was posted by a user wishing to remain anonymous
    Posted 02-Jul-2021 14:55
    This message was posted by a user wishing to remain anonymous

    Monir El Azzouzi did a fantastic session at the free Greenlight Guru True Quality Summit called How to Create Medical Device Labels per EU MDR and then he did a Q&A on his Easy Medical Device podcast/YouTube later:

    https://mdr.greenlight.guru/talks/how-to-create-medical-device-labels-per-eu-mdr/

    Leo Eisner is giving a free webinar on the new standard for symbols in a couple days:
    https://eisnersafety.com/2021/06/23/attention-%e2%9a%a0%ef%b8%8f-iso-15223-1-4th-edition-is-almost-here-how-to-update-your-medical-device-labeling-to-comply-with-new-the-requirements/
    Original Message


  • 7.  RE: Medical Device Labeling Standards

    Posted 03-Jul-2021 02:22
    Edited by Leonard Eisner 03-Jul-2021 02:27
    One other thing to consider similar to a product requirements specification is 1) a label requirements specification, 2) an IFU requirements specification,  and if applicable to your device 3) is a service manual specification.  These are great tools for the early design input specification process that capture these inputs early in the process.  Inputs for these documents include various applicable standards, regulations, guidances, Directives, etc. that apply to the device that should be considered while it is being designed.

    I find this very helpful when dealing with medical electrical equipment but also active implantables, and I can see the same for non-active devices as well as there are a whole slew of labeling and manual requirements from a far ranging set of requirements.  Some requirements will also come from your own specifications, as well.

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    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
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    Original Message


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