We had a technical review for a new class IIb product last week and it was kicked back because we did not state whether we marketed the device outside of the EU.
I maintain that this is not relevent to the review however they are persisting that we must inform them before they will approve the device. Does anyone have any experience with this/any suggestions? Are they actually justified in asking this?
Yes we can tell them however it's the principle if we are not required to!
I maintain that this is not relevent to the review however they are persisting that we must inform them before they will approve the device. Does anyone have any experience with this/any suggestions? Are they actually justified in asking this?
Yes we can tell them however it's the principle if we are not required to!