Merge Technical File, DMR, and Device File into a single document?

Mark Meer

Trusted Information Resource
#1
Given that we market in the United States and in Europe, and maintain an EN ISO 13485:2016 quality system, we have the following documentation requirements for each project:
  • A "Medical Device File" (as required by EN ISO 13485:2016, 4.2.3)
  • A "Technical File/Design Dossier" (for CE Marking)
  • A "Device Master Record" (as required by 21 FDA CFR §820.181)
There is a tremendous amount of redundancy between these documents. Does anyone see any issue with simply merging these into a single document that meets all requirements?

Input much appreciated!
 
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S

SteveK

#2
As far as I am concerned the ‘Medical Device File’ and ‘Technical File’; for our intent and purposes for EU compliance (Class Im, IIa & IIb devices), are one in the same document (we do not supply to the US).

Steve
 

paulag

Involved In Discussions
#3
Technical file and medical device file is the same thing. We always called it technical documentation, just like the new EU MDR does.

The DMR is our basic documentation for each product, whereas some documents are only created for technical documentation of medical devices - essential requirements, clinical Evaluation, classification, declaration of conformity, etc. So we take these and reference specifications, drawings etc from the respective DMR, et voila, a TD!
 

Mark Meer

Trusted Information Resource
#4
I was thinking the following:

Have a "Part A" and "Part B" corresponding to a "summary" (basic product information) and "details" (detailing risk, specifications, processes, V&V...).

Most (all?) of what is required in the Device Master Record would be contained in "Part B".
 
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