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  • 1.  Do you CE Mark if you are private labeling for a US only distributed product?

    Posted 21 days ago

    Hello, 

    I am looking to understand the need for a CE mark on a product that will be distributed to the US only but the manufacturer is in the EU. They will private label their product with the US branded distributor info but are keeping the CE mark and EU Rep info on the label. Is this ok to have or should it be removed?



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    Nina Chiang
    Regulatory Affairs Specialist
    Glidewell Dental
    Irvine CA
    United States
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  • 2.  RE: Do you CE Mark if you are private labeling for a US only distributed product?

    Posted 21 days ago

    There is definitely no "need" (i.e., European Regulation 2017/745 or /746 legislative requirement) for a CE mark on a medical device manufactured in the EU for distribution in the U.S.  CE marking only pertains to devices placed on the market in Europe's Union.

    Moreover, it is most ideal (and arguably required) that the CE mark and EU Rep info be removed from the U.S. labels/labeling in order to assure the most succinct compliance with FDA's medical device labeling requirements. This would generally provide the best assurance for avoiding a U.S. "misbranding" situation and/or a "wrongly affixed CE mark" situation.

    That said, if you have a solid ISO 14971 risk analysis confirming that the presence of the CE mark and EU Rep info on the U.S. device label doesn't cause the device to fail to meet risk acceptance criteria (such as by confusing the labeling; creating false or misleading implications; etc.), then perhaps it could be justified (though still not recommended) to leave the CE mark and EU Rep info on the U.S. device labels.  In such case, I would be sure that the U.S. units contain a symbols glossary explaining that the CE mark and EU Rep info are not applicable for the U.S. And to avoid a wrongly affixed CE mark situation, it would be best to assure that such a U.S. device actually does fully conform with Europe's CE marking requirements.  Yet these safeguards would entail a labeling change(s) and compliance activities that would be more burdensome than just having a U.S. version without the CE mark and EU Rep info...



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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  • 3.  RE: Do you CE Mark if you are private labeling for a US only distributed product?

    This message was posted by a user wishing to remain anonymous
    Posted 17 days ago
    This message was posted by a user wishing to remain anonymous

    As Kevin says, you have options. If it were up to me, I wouldn't pay our EC REP to represent a product we'll never take over there, so I'd have the CE mark and address removed. If I thought we'd be expanding into that market soon, with no other labeling changes needed, I might go ahead and assemble the technical documentation, register it with the REP and keep the CE mark.




  • 4.  RE: Do you CE Mark if you are private labeling for a US only distributed product?

    Posted 16 days ago

    Hello and thank you for your reply. To Kevin and everyone here on this thread, the label is the privately labeled for many different companies so some of the info is "mandatory". In the development and registration process, the manufacturer always CE marks according to MDR and adds their rep on there, even if the product is not marketed there. Legal manufacturers of this device own the label I assume then and can do what they want with it?



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    Nina Chiang
    Regulatory Affairs Specialist
    Glidewell Dental
    Irvine CA
    United States
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  • 5.  RE: Do you CE Mark if you are private labeling for a US only distributed product?

    Posted 16 days ago

    Hi Kevin, thank you for your response. I had a question I posed within the thread but I'll post it here too in case it doesn't alert you. The label is privately labeled for many different companies so some of the info is "mandatory", the manufacturere has stated. In the development and registration process, the manufacturer always CE marks according to MDR and adds their rep on there, even if the product is not marketed there. Legal manufacturers of this device own the label I assume then and can do what they want with it? If they are firm on keeping the CE mark on the label, what would the private labeler (US market only) need to do?



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    Nina Chiang
    Regulatory Affairs Specialist
    Glidewell Dental
    Irvine CA
    United States
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  • 6.  RE: Do you CE Mark if you are private labeling for a US only distributed product?

    Posted 19 days ago

    Hi Nina,

    I agree with Kevin: It is possible to leave the CE mark on the device, but you would need to take care that the device still fully complies with EU requirements and you might need to explain that this has not applicable for US. I normally would recommend removing the CE mark. This avoids confusion and ensures that devices meant for the US cannot be re-imported into the Union (which would be possible if the CE mark remains).

    Best regards

    Christoph



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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  • 7.  RE: Do you CE Mark if you are private labeling for a US only distributed product?

    Posted 16 days ago

    Thank you for your reply. Do you know if there is a regulation or in the EU MDR where it states it is mandatory for a product to be CE marked for a private labeler even if the product is made in the EU and distributed to the US only. The manufacturer is firm on not removing the CE mark. 



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    Nina Chiang
    Regulatory Affairs Specialist
    Glidewell Dental
    Irvine CA
    United States
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  • 8.  RE: Do you CE Mark if you are private labeling for a US only distributed product?

    Posted 16 days ago

    No, it is generally not needed to keep the CE mark and EU Rep info on a product distributed solely in the US, 

    But if the SKU is a global one you can justify why the label is same across the globe



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    Dinesh Puppala RAC
    Regulatory Affairs Lead
    Google LLC - ENTERPRISE
    Mountain View CA
    United States
    Linkedin - https://www.linkedin.com/in/dinesh-puppala/
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