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MDR (Medical Device Reporting) Justification - Canned Statements

S

singber

#1
My company (class I and II medical device software manufacturer) is revising our MDR procedures. During Management Review of potential patient safety issue, executives with clinical knowledge document our decision whether or not to file an MDR (we have a flowchart that we follow). Besides the flowchart, we also add a written justification for those issues that do not require an MDR.

I have been asked to come up with a list of "canned" justifications for not submitting MDRs and wanted to know if anyone had anything like this already. Of course, there would be times when a canned justification could not be used and a new justification would be written.

Thanks!
 
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Stijloor

Staff member
Super Moderator
#2
My company (class I and II medical device software manufacturer) is revising our MDR procedures. During Management Review of potential patient safety issue, executives with clinical knowledge document our decision whether or not to file an MDR (we have a flowchart that we follow). Besides the flowchart, we also add a written justification for those issues that do not require an MDR.

I have been asked to come up with a list of "canned" justifications for not submitting MDRs and wanted to know if anyone had anything like this already. Of course, there would be times when a canned justification could not be used and a new justification would be written.

Thanks!
Can someone help with this?

Thank you very much!

Stijloor.
 

pkost

Trusted Information Resource
#3
I would be wary of using canned responses, certainly there are issues that arise regularly that could be dismissed and not reported, but if you just give a canned response such as "device not used as intended" then you haven't really justified your decision...how did you reach that decision?

I have limited experience in other device areas, but about the only canned response I think that I could really get away with is...This is not a reportable incident by acme corp as acme corp are not the manufacturers of this device.

You could "code" your complaints/issues for internal use so that you could track trends. Sticking with the not used as intended issue then if there was spike for a particular product group it may lead you to investigate why it was being misused and what you should do to prevent the misuse. But that isn't a justifcation - that's coding!
 
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