CE Risk Assessment
Hi there,
I am about to bring a new product to market. I notice that it asks if I need a CE risk assessment.
Now my product on its packaging displays a CE mark however it does not need to be notified by an authoritative body. All that is required from me is a declaration of conformity (DoC), now I have created this and it is all prepared in case amazon needs it. But I am unsure whether I need to press the button that says I need a risk assessment. To give you some context my product comes under a Class 1 medical device.
If anyone can help I would be extremely grateful
Thank you
CE Risk Assessment
Hi there,
I am about to bring a new product to market. I notice that it asks if I need a CE risk assessment.
Now my product on its packaging displays a CE mark however it does not need to be notified by an authoritative body. All that is required from me is a declaration of conformity (DoC), now I have created this and it is all prepared in case amazon needs it. But I am unsure whether I need to press the button that says I need a risk assessment. To give you some context my product comes under a Class 1 medical device.
If anyone can help I would be extremely grateful
Thank you
13 replies
Julia_Amzn
Hello @ SafeBody,
Thank you for reaching out to us!
@ The_Little_Shop - thank you for the valuable information provided.
@ SafeBody, I am sharing link to the Seller University for the review. You can also contact the Seller Support and ask for more insights. CE mark is a very important part of the compliance policy, which is randomly reviewed by our internal teams hence I suggest to double check all the requirements before you list your products.
EU and UK Product Compliance Guidance – CE and UKCA Marking
Kind regards,
Julia.
