MDR technical file: does it need to contain duplicates of controlled documents

DannyVerbiest

Starting to get Involved
#1
Hi,
We currently have a physical binder containing all documents that are part of our device's technical file.
Of course, if one of these documents gets an update, we have to make sure to print and update our physical binder to avoid descrepancies.

My question:
- is it possible to create a technical file that refers to documents rather than having the actual document duplicated and saved in the file?
- if above is possible, is it required to have a version for each document that is part of the TF? I presume it is...

Thanks in advance for your feedback!
 
Elsmar Forum Sponsor
#2
Hi,
We currently have a physical binder containing all documents that are part of our device's technical file.
Of course, if one of these documents gets an update, we have to make sure to print and update our physical binder to avoid descrepancies.

My question:
- is it possible to create a technical file that refers to documents rather than having the actual document duplicated and saved in the file?
- if above is possible, is it required to have a version for each document that is part of the TF? I presume it is...

Thanks in advance for your feedback!
1. My notified body doesn't seem to have an issue with us referencing documents if that's what you mean?
2. If the document in question is controlled then it needs to have a version number
 

Cybel

Involved In Discussions
#3
- is it possible to create a technical file that refers to documents rather than having the actual document duplicated and saved in the file?
Yes, providing that in the TF you indicate review number and date of the referred document and that is reflects the most updated document at any time.
My NB does not accept non-controlled documents referred to in the TF.
 
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