Regulatory Open Forum

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?

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...

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?

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.

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...

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?

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...

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?

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?

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

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?

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?