Private label issues For EU - Customer does not have CE Mark

[ortal]

Hi all,

There's an issue I'm constantly dealing with.
I would be happy if you could help me understand once for all.
For EU - can I produce a private label for a customer who does not have a CE? meaning the product will be with the CE of my company.
In other words, in the label there is the customer's brand, CE and European representative of our company, the manufacturer symbol is with my company details and it is also written that our client is the importer.

meaning -
My company as the manufacturer owns the CE, EC REP, maufacturer details.
My customer as the importer and the brand name (with company logo)
I hope I've managed to explain myself.

 

[Al Rosen]

Hi all,

There's an issue I'm constantly dealing with.
I would be happy if you could help me understand once for all.
For EU - can I produce a private label for a customer who does not have a CE? meaning the product will be with the CE of my company.
In other words, in the label there is the customer's brand, CE and European representative of our company, the manufacturer symbol is with my company details and it is also written that our client is the importer.

meaning -
My company as the manufacturer owns the CE, EC REP, maufacturer details.
My customer as the importer and the brand name (with company logo)
I hope I've managed to explain myself.

Yes, as long as the importer assumes the responsibilities of the manufacturer and has access to the manufacturer's design and manufacturing information. Look here for more information.

 

[ortal]

Thank you so much! and then we can produce labels with our CE and the importer's brand? I did not saw any reference to this situation anywhere ...

 

[somashekar]

Thank you so much! and then we can produce labels with our CE and the importer's brand? I did not saw any reference to this situation anywhere ...

Its a label type and you have to put this label type also into your technical file. The label will also have your Ref number for the product (device) that has the CE mark for you.
With Manufacturer symbol., your name and address.
With EU rep symbol., your EU rep name and address.
The product name and Ref No. ., as in your CE certificate.
Please also inform your NB and your EU rep, and share the updated technical file having the new label style with your NB for record.

 

[ortal]

Thank you very much

 

[supadrai]

Hi ortal,

We produce OEM/private label low-risk medical devices for a lot of brands in the EU. The CE mark is with us because the medical devices are of an appropriate risk class to allow us as manufacturer to self-declare and apply the mark. So just make sure your risk class allows you and your distributor to self-certify and you're okay to apply it.

 

[ortal]

It's Class IIa products.. What does it means? I can't do it?

 

[ScottK]

It's Class IIa products.. What does it means? I can't do it?

I think you're OK
IIa means you can't self-certify, you have to have some sort of conformity assessment by an NB, but you should still be able to do what you a planning as far your customer relationship.

You still own the mark. Are you outside of the EU? If so then you also have to have an authorized representative in the EU.