Hi Everyone!
I am currently in the process of researching the requirements for CE marking my company's class IIa medical device. I understand that we can follow either Annex II or Annex VII.
However, if we select to follow Annex VII (which is the way we'll go) are we required to complete the other three Annexes associated with class IIa (i.e. Annex IV, V, VI)?
Or, do we complete just Annex VII and one of the other Annexes (IV, V or VI) to demonstrate conformity with the MDD and ER?
Regards, Tonia
I am currently in the process of researching the requirements for CE marking my company's class IIa medical device. I understand that we can follow either Annex II or Annex VII.
However, if we select to follow Annex VII (which is the way we'll go) are we required to complete the other three Annexes associated with class IIa (i.e. Annex IV, V, VI)?
Or, do we complete just Annex VII and one of the other Annexes (IV, V or VI) to demonstrate conformity with the MDD and ER?
Regards, Tonia