Product Group Approval Request - Medical Supplies and Equipment

I have been trying to submit the right documentation to get approved for selling in the Splints category (under medical supplies and equipment), but my manufacturer cannot supply the declaration of conformity as demanded by Amazon.

Amazon are asking for the following:

Show compliance with the most recent Directive on Medical Devices with date
Show compliance with the most recent EN testing standard with dates
Contain name of the manufacturer
Include product, trademark or model number
Include binding signature from empowered person(s)

The manufacturer which is quite a large one based in China said that none of the previous sellers have had to supply any of this information before. Is this something new Amazon is asking?

I really seem to be getting nowhere with this. What proof of “showing compliance” with EN testing standards, etc. does Amazon require?

To put the cherry on top, in a recent correspondence email they also pointed out that I do not have the CE symbol on my packaging. Prior to designing my packaging I ordered some of my competitors’ products to see what I actually need to include and none of these have the CE symbol, or even list their address on the packaging (which I am mentioning). Why is Amazon allowing some of the sellers to get away with minimal things and appear to be coming after new sellers who are trying to build up a trademarked brand and selling superior products.

What can I do with regards to this declaration of comformity? I am not even able to list the product under a different category as I have tried to list it under Sports Equipment -> Splints and it gets moved to Medical Supplies everytime.