Hi
We are developing a new product, that will be covered under our existing CE Scope (the product is the same Classification - Class IIb), will our Product Technical File require a review by the Notified Body.
Also, our current CE is only just recently under MDD (Annex II w/o 4), however, will we need to apply MDR to this new product.
I've been getting conflicting information on various websites, so not entirely sure.
Thank you in advance.
We are developing a new product, that will be covered under our existing CE Scope (the product is the same Classification - Class IIb), will our Product Technical File require a review by the Notified Body.
Also, our current CE is only just recently under MDD (Annex II w/o 4), however, will we need to apply MDR to this new product.
I've been getting conflicting information on various websites, so not entirely sure.
Thank you in advance.