S
Hi,
I understand that part of the CE marking requirements for a medical device is to hold a Technical File for the device in the EU.
Most of this file will come from documents in our Device Master Record (DMR).
I was wondering if anyone knows the requirements for updating the Technical File? As we are a manufacturer outside the EU, do with have to update the Technical File every time one of our DMR (controlled) documents changes?
thanks
Simon
I understand that part of the CE marking requirements for a medical device is to hold a Technical File for the device in the EU.
Most of this file will come from documents in our Device Master Record (DMR).
I was wondering if anyone knows the requirements for updating the Technical File? As we are a manufacturer outside the EU, do with have to update the Technical File every time one of our DMR (controlled) documents changes?
thanks
Simon