We are a *** based company who manufacture dental instruments, under the name of ***.
a) We export to EU and USA,
b) We do not sell by our own name
c) We stamp the brand or name of the company we export, on the instruments.
Now, we are in contact with a European company for acting as our EU AR.
They say: ***, by MDR definition, is not a "legal Manufacturer", as *** is not selling in the EU by its own name or brand.
So we can not act as *** EU AR.
My questions are:
1. Are they right in their observation?
2. We need aan EU AR or not?
3. If not, then, what should we declare on the labels, *** as Contract Manufacturer?
Please help us and guide us in this regard.