CE Registration - Product Manufactured in 2 Countries

[windyridge828]

2 Questions:

1. Can you manufacture a product in the US (not CE certified) and have a manufacturer in Germany assume the manufacturer role (if we private label for them). Can they be CE registered and have the CE mark on the product that is manufactured in the US?

2: A manufacture according to ISO is whoever’s name is on the product? Is this true?

 

[moounir]

Hi Windyridge,

I think you are an OEM and want to sell your product to a PLM (Now called Virtula Manufacturer). Am I right?
In the case of the new Medical Device Regulation that will be effective by May 2020, this will not be really possible anymore.

Unless you accept to give the Technical File and all the information about your product to the PLM. Because now the rule is that the PLM will need to register the product and provide the Technical File and all documentation required for a manufacturer.

Before it was authorized to have the certificate of the OEM but not anymore feasible.

Let me know if this answers your question.

 

[Lorenzo]

If I assume that you are an OEM, you could offer your customer to put "Distributed by customer name" on the label.

Please also note that you are not allowed to import a CE-relevant product without an EU representative.