Piggy Backing on OEM's CE certificate

[Mor628]

Hi guys,

We've been waiting for a really long time to get our new products CE marked. But we have huge demands from our customers for the product and unable to sell due to the product not listed on the CE cert.

Is there a way we can piggy back on our OEM's CE certificate and sell the device? The manufacturer and EC Rep on the product label will now be the OEM instead of us (the OBL) as a temporary solution?

 

[Sulamistan]

There has been some discussion around this topic in the following thread,

https://elsmar.com/Forums/eu-medical-device-regulations/71414-medical-devices-sourced-contract-manufacturers-legal-manufacturer.html[/URL]

Please check if it answers your question, unfortunately, I cannot post the link to the thread.