We currently have a CE Mark and can distribute to the EU countries. We have a sister site in the UK, they want us to sell our device to them and they in turn want to sell the product. What does out sister site in the UK need (lisences etc ) to do this? Life would be simple if we could cut them out and sell direct, I know.:notme:

Since your question has to do more with CE marking I moved it to that forum...

(I'm not a medical device manufacturer but I'm interested in the responses you get.)

It depends on whether your sister site is appointed as Authorized Representative or as distrubutor.

Rob Udo.

They are our Authorized Rep

They are our Authorized Rep
Seems you are based out of the EU and hence you have appointed your sister company as your authorized EU rep. (Correct me if wrong)
You are the legal manufacturer as I understand and your sister company can double up as a distributor. That is your call.
However I believe your sister company have all the credentials and competency to act as your EU rep and your notified body has recognized this.
Are you doing any labelling changes when distributed through your sister company ? Take care you do NOT. I suggest you have a seperate distribution agreement made and respected apart from the EU rep agreement.

We are located in the USA. Sister company in UK. No label change, seems a way to spread the "wealth" so to speak, everyone gets a cut.

Go ahead. No CE issues.

Your sister concern does not have to buy and then sell. They can source it from you for their customer and pocket a commission. But thats a commercial issue. Best left to your management.

I think potdar is right,no CE issues are required.

Hi,

I am looking at a scenario where
Company A is the OEM manufacturer and has CE marking on the product
Company B is the Private Labelled Manufacturer getting all the manufacturing, integration and testing done by Company C. On its own it will be having only Sales and after sales, service support.

How can Company B get the CE mark on the product in its name?

I have a similar situation, but I manufacture and distribute in the UK and have a sister comany in mainland Europe, it depends who holds the CE mark, do you or did your sister company actually ce mark the product? If you hold the CE mark then in Europe its your name and address that goes on the packaging next to the CE mark, which must be a European address. If they hold the ce mark then it is them. Regarding selling, it is a commercial agreement, do they have exclusivity for the UK? If so then you wont be able to sell into the uk, the agreement should have a time period and or hold them to min sales, if they dont reach the min they can lose exclusivity and you can step in.

Company B has not yet got into the CE marking process. In fact the whole deal is in its early stages. I need to get clarify about the process of getting the product CE marked in Company B's name. How to go about it.

Company B is in a different country to the source company - Company A.


Thanks for pitching in

and...........Remember to look at your Notified Body conditions of contract. They will need to be aware of significant changes before you even implement them.