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


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Some Related Topic Tags (Not all threads are Tagged)
21 cfr part 820 - med. device mfger. qsr requirements, ce mark and ce marking, device master file, device master record (dmr), fda (food and drug administration), iso 13485 - medical device qms, technical files for medical devices
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  Post Number #1  
Old 12th July 2017, 06:16 PM
Mark Meer

 
 
Total Posts: 611
Question Merge Technical File, DMR, and Device File into a single document?

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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  Post Number #2  
Old 13th July 2017, 04:03 AM
SteveK's Avatar
SteveK

 
 
Total Posts: 783
Lurker Re: Merge Technical File, DMR, and Device File into a single document?

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
Thanks to SteveK for your informative Post and/or Attachment!
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  Post Number #3  
Old 13th July 2017, 08:03 AM
paulag

 
 
Total Posts: 58
Re: Merge Technical File, DMR, and Device File into a single document?

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!
  Post Number #4  
Old 13th July 2017, 11:56 AM
Mark Meer

 
 
Total Posts: 611
Re: Merge Technical File, DMR, and Device File into a single document?

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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