B
brandtpeters
Hello, we wish to register a new Class IIb medical device. We wish to use the Annex II route. We have created a technical file in order to self declare.
This new medical device isn't covered by the scope of our existing iso13485 certificate, therefore do we have to update the 13485 scope before we can attach a CE mark?
Thanks
This new medical device isn't covered by the scope of our existing iso13485 certificate, therefore do we have to update the 13485 scope before we can attach a CE mark?
Thanks