CE Marking of Performance Controls

M

ManTheDan88

Hey all.

We are currently selling performance controls to a customer in France without the controls CE marked. All we do is attach the "For Evaluation Purposes Only" label and send it on its way. Now our customer wants to CE mark our product under their name and are asking for stability data. So my question is, do our controls need to be CE marked before they submit for CE marking? Or is ok to keep sending our product with the "For Evaluation Purposes Only" label and let them CE mark the product under their name even though they are not the manufacturer?

Thanks in advance.

-D
 

CharlieUK

Quite Involved in Discussions
Generally:

- only the manufacturer knows enough information to be able to declare compliance. If they sell the product under their own name they are still dependant on you for compliance - for example that you haven't changed the product without telling them.
This type of arrangement is fairly common and should be covered by a commercial contract and them performing due diligence on your CE marking compliance.

- you can't keep selling them product and pretending the product is for evalution purposes only. This is basically illegal.

That said - what are your "performance controls" - they only need CE marking if they fall under one or more Directive that require it - if you provide us some more information I'm sure you'll get some more advice.

Charlie
 
M

ManTheDan88

The performance controls are just positive and negative controls for a lateral flow device.
 
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