Requirements for Updating a Medical Device Technical File

S

s.parakos

#1
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
 
Elsmar Forum Sponsor
W

wrodnigg

#3
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.
 
R

redknight07

#4
But if there were no changes to the device records, in that case is there any obligation to update the technical file?! For instance, every two years even if the documentation is supposed to be identical.

Cheers,
Aniket
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Hi,

It is the manufacturer's onus to ensure that the Technical File is up to date at all times. One may want to proceduralise a periodic review (e.g. once a year) and document that there were no changes if that is the case; however HOW a manufacturer ENSURES that the Technical File is up to date is up to them.

Cheers,
Ronen.
 

rangani_rj

Involved In Discussions
#6
Hi,

Particularly keep eye on clinical part of medical device. As soon as new information available (from equivalence device news or literature search) for supporting use of your device or regarding adverse effect, you need to update accordingly in technical file.
 

Oz32

Registered
#7
I stumbled upon this older thread but was hoping someone could assist; is there a requirement for the frequency of how often the manufacturer has to perform an internal review of Technical files?
 
#8
Review of the Technical Files would be part of your Internal Audit programme. See 13485 clause 8.2.4

The audit programme has to be planned but the intervals are for the manufacturer to define (and document and justify).
 

Marcelo

Inactive Registered Visitor
#9
Review of the Technical Files would be part of your Internal Audit programme. See 13485 clause 8.2.4

The audit programme has to be planned but the intervals are for the manufacturer to define (and document and justify).
What does the technical file has to do with auditing? The technical file should be reviewed whenever the information it contains change. This is to demonstrate the "product safety and effectiveness" aspect of the regulations, and this has always have to be up-to-date (not waiting an audit, which is related to the QMS aspect of the regulations).
 
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