Own Brand and Trademark Labeling Question

C

chudsy

#1
Hi All,
Just looking for clarification on this. We market a product with a registered trademark (not ours) but have given it a name unique to our market. The packaging and device is covered with the trademark and our product name is not written on the device.
If I write our product name on the instructions as well as the OEM part number and trademark would it make us an OBL??
Thanks
 
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pkost

Trusted Information Resource
#2
Re: Quick Own Brand Labelling Question

This simple question needs a few more details!

Is the device already CE marked by the original manufacturer? If no then you are certainly the manufacturer

Does the original manufacturers CE mark and the original details remain with the device - if yes then they are the manufacturer.

As a distributor, you are able to apply your own name to a device without becoming the legal manufacturer. Although it does have to remain clear who the original manufacturer is - different states interpret this differently.


Your original post suggest that you are modifying the IFU...this is risky - how do you know if the OEM changes the information on it, how do you ensure your's is always accurate. If you change information (even if it is accidental because you didn't notice the OEM's change) then you become the legal manufacturer!

trademarks are irrelevent in the identification of a legal manufacturer.
 
C

chudsy

#3
Re: Quick Own Brand Labelling Question

Thanks for that.
It looks like we may be inheriting the 'manufacturer' title from a previous EU rep and would compile new tech files.
Who would be responsible for legacy products previously supplied?
The only change would obviously be the EU rep & distributor info.
 

pkost

Trusted Information Resource
#4
Re: Quick Own Brand Labelling Question

I'm a little confused by your question, how have you "inherited" the manufacturing title from a previous EU rep - an EU rep is not a manufacturer, they are merely a representative in the EU for the legal manufacturer who is outside of the EU.

The person responsible for the products is always the manufacturer. If you are acting as an EU rep then you would be an EU point of contact, but you would refer everything (including legacy products) back to the legal manufacturer.
 
D

Deanb

#5
Re: Quick Own Brand Labelling Question

As a distributor, you are able to apply your own name to a device without becoming the legal manufacturer. Although it does have to remain clear who the original manufacturer is - different states interpret this differently.


trademarks are irrelevent in the identification of a legal manufacturer.
pkost, Can you link the EU regulation you've gotten this information from? In all of my reading, I've become convinced that by applying a Distributor name or trademark to a device, you become the effective manufacture according to EU regulation. With the FDA, I'm in agree with you 100%.

I found this thread as I'm looking for clarification as to the contents of the device label and labeling on the back of the device for private labeled Class I medical electronics. I have a device which I want to buy from company A, who has already created a technical file/DoC and has self-certified for a CE mark. They are willing to put my company name on the front of the device, but all other device labeling will refer to their company. There will be a label on the back of the device with manufacturer information, which will provide their information, but my name will be on the front. I'm hoping that if you can provide a link to the EU regulation that covers this, I'll be able to make sense of my situation!
 

somashekar

Staff member
Super Moderator
#7
Re: Quick Own Brand Labelling Question

pkost, Can you link the EU regulation you've gotten this information from? In all of my reading, I've become convinced that by applying a Distributor name or trademark to a device, you become the effective manufacture according to EU regulation. With the FDA, I'm in agree with you 100%.

I found this thread as I'm looking for clarification as to the contents of the device label and labeling on the back of the device for private labeled Class I medical electronics. I have a device which I want to buy from company A, who has already created a technical file/DoC and has self-certified for a CE mark. They are willing to put my company name on the front of the device, but all other device labeling will refer to their company. There will be a label on the back of the device with manufacturer information, which will provide their information, but my name will be on the front. I'm hoping that if you can provide a link to the EU regulation that covers this, I'll be able to make sense of my situation!
All the information of the manufacturer which will be on the label having details to regulatory requirements is maintained and the product can be labeled with the distributors details (name, address, branding) including his re-order code and his label color preferences and style. This label can be an other style of the product label mentioned within the manufacturer's technical file.
This is meeting commercial and business requirements same time respecting all the regulatory requirements. EU regulations does not say how business can be made. It stops at the legal manufacturer's meeting all the regulations stipulated for his class of device.
(Please do not alter the manufacturer provided label or add your own label over that of the manufacturer)
 
Last edited:
R

retired

#8
Re: Own Brand and Trademark Labelling Question

can anyone tell me if the original manufacturer of the product has to be listed on the certificate of conformance if I an the Own brand labeler
retired
 

pkost

Trusted Information Resource
#9
Re: Own Brand and Trademark Labelling Question

There is no requirement for you to name the original manufacturer...I can't give you a reference. Just personal experience
 
V

Volfhart

#10
Re: Own Brand and Trademark Labelling Question

I have a similar question as "retired". Have not seen a reply to his question.
If we private label a device (Class IIa) and put our name on it, the operating manual and of course the promotional materials, do we need to list the owner/designer/manufacturer company on our CE certificate? The original manufacturer has his own CE certificate.
Thanks all.
 
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