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

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
SimonYes, you need to update your technical file.

I agree with Al.

Every time you have new information, which cause a revision of your FDA-DMR, you have to update your EC-DMR (= Technical File)

I would issue a critical non conformity if you would not do do so.