Requirements for Updating a Medical Device Technical File

[s.parakos]

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

[Al Rosen]

Originally Posted by s.parakos

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

Yes, you need to update your technical file.

[wrodnigg]

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.