Sales in Europe of CE marked Medical devices with sister company

[Achemd]

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.

[ScottK]

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.)

[Rob Udo]

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

Rob Udo.

[Achemd]

They are our Authorized Rep

[somashekar]

Originally Posted by Achemd

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.

[Achemd]

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.

[potdar]

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.

[maxenix]

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