Hello,
i was wondering, if there is a counterpart to the GSPR (Annex I MDR 2017/745/EC) or the General Requirements (Annex I MDD 93/42/EEC) in the USA? In Europe there is with Annex I a very detailed list (23 Parts) about the safeness and performance requirements a medical device have to fulfill to get market access.
I would like to compare the list in Europe with the list in the USA if there is one, but I was not able to find it, anybody got a tip for me? Or are the requirements for medical devices only determined via the QSR CFR 820?
I thank you in advance for every clue,
thanks!
Paul
i was wondering, if there is a counterpart to the GSPR (Annex I MDR 2017/745/EC) or the General Requirements (Annex I MDD 93/42/EEC) in the USA? In Europe there is with Annex I a very detailed list (23 Parts) about the safeness and performance requirements a medical device have to fulfill to get market access.
I would like to compare the list in Europe with the list in the USA if there is one, but I was not able to find it, anybody got a tip for me? Or are the requirements for medical devices only determined via the QSR CFR 820?
I thank you in advance for every clue,
thanks!
Paul