Hi,
The MDR states that the EU DoC must contain (ref Annex IV (8)) that 'where applicable.... a description of the conformity assessment procedure performed'
In the case of class I medical devices, does anybody know how to state which conformity assessment route is used, which part of the MDR should be referenced? or if you do not need to mention conformity assessment route as they are class I?
The class I devices we manufacture are simple class I, not sterile etc
Thank you for any help!
The MDR states that the EU DoC must contain (ref Annex IV (8)) that 'where applicable.... a description of the conformity assessment procedure performed'
In the case of class I medical devices, does anybody know how to state which conformity assessment route is used, which part of the MDR should be referenced? or if you do not need to mention conformity assessment route as they are class I?
The class I devices we manufacture are simple class I, not sterile etc
Thank you for any help!