Regulatory Open Forum

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  • 1.  Anonymous question on IFUs

    Posted 28 days ago

    Dear RAPS community,

     

     

    After MDR transfer the IFU usually changes a lot. We do not always opt for a new 510(k). Instead, for deliveries to the US, we plan to remove the CE IFU from the box and replace it with US IFU. Is this still compliant with the MDR, and towards FDA, as the device label carries a CE mark? To note, for logistic reasons we cannot create double items (REF/UDI) for separate markets.

     

    If we choose eIFU for USA, does FDA require a symbol for eIFU in the label or carton box? We do not use the actual eIFU per Regulation 2021/2226, so we cannot use the ISO 15223 symbol on the label.

     

     

    Thank you for all your comments!



  • 2.  RE: Anonymous question on IFUs

    Posted 27 days ago

    Hello Kati,

    The regulatory requirements in the US and EU are different, so recognition of items, information, or content does differ between the two regions.  However, it has been generally accepted - at least by the US FDA - when there is other regulatory information like a CE Mark this is accepted.  Of course, this is considering the organisation is meeting those requirements for how they are indicating the status of the product, i.e. having a CE Mark.

    The US FDA has recognised electronic Instructions for Use (eIFU) for a long time now and as you are probably aware much more aligned to current industry needs, unlike the EU.  There should be an indication on the labelling that an eIFU is available and where located.  If the label is in English, there is no requirement for translation, so a symbol is not necessarily needed.  However, generating labelling content to meet different regulatory jurisdictions can be challenging because of the differences, so careful planning should be considered.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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    Original Message


  • 3.  RE: Anonymous question on IFUs

    Posted 26 days ago

    Hello Kati,

    Based on the information provided, I would remove the CE mark from the device that doesn't carry the MDR-compliant IFU. A CE-marked product in distribution, even if only in the US, should meet the requirements of the CE mark.

    -Emily

     

    Emily Nesbitt

    Director, Regulatory Affairs

    Capital, Software, Cybersecurity

    MedTech Surgery

     

    enesbitt@Its.jnj.com

    jnj.com

     

     




    Original Message


  • 4.  RE: Anonymous question on IFUs

    Posted 27 days ago

    Dear fellow RAPS Member

    For the US you can provide the IFU in electronic format exclusively if the device is intended to be used by professionals only and if you indicate how the device user can obtain a paper copy of the IFU. There needs to be an indication on the device labeling on how to access the electronic IFU, typically this is a URL such as ifu.yourcompany.com. 

    For the EU, you can provide electronic IFU and paper IFU in parallel. In this case, I am unaware of any specific regulatory reason for not using the ISO 15223 symbol for eIFU on the device labeling. 

    For medical implants, you can completely remove the paper IFU. This is a more extensive project because device packaging is involved and your notified body needs to assess the change and your eIFU system.

    Best regards,

    Hans



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    Hans Strobel
    www.dokspot.io
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    Original Message


  • 5.  RE: Anonymous question on IFUs

    Posted 27 days ago

    Hi Kati,

    one additional detail: If you remove the CE IFU from the box, then the device is no longer MDR compliant. This might be a problem if someone decides to re-import the devices into the EU and they turn up there with a CE mark and the wrong IFU. If you want to leave the CE mark on the box, the device including labeling and IFU must be MDR compliant.

    In addition I don't think you can use the same REF/UDI if the content of the box differs.

    Best regards, Christoph



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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    Original Message


  • 6.  RE: Anonymous question on IFUs

    Posted 26 days ago

    Which ever market that you sell, you have to abide to the legal regulatory requirements.

    Labelling requirements are different between USA and EU/Union and need to be considered as outlined. The MDR Annex I contains a lot of detail for labelling. 

    As the other participants have noted, not all medical devices are allowed to have e-IFU which is utlined in e-IFU Regulation 2023/226. 

    https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R2226&qid=1713334553403

    EU states they have Green Deal Industrial Plan etc.

    Why though do they keep the use of e-IFU restricted to specific devices?

    https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal/green-deal-industrial-plan_en

    https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal/delivering-european-green-deal_en



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    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
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    Original Message


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