CER Adverse events - Justification of databases searched

MDRexpert

Involved In Discussions
#1
We have picked few national databases for our adverse event search - example Maude, MDR, Swiss medic, FSCA and TGA.
How do you justify why these databases were picked over other? Does MEDDEV specify anything related to database used or providing rationale for it?
 
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shimonv

Trusted Information Resource
#2
From my own experience, you don't need to justify which databases you used. Actually, they are very few good ones out there and they know it. If you use the databases which you mentioned in your post you should be fine.
 

Watchcat

Trusted Information Resource
#4
I've never seen any indication that the notified bodies care if the database and the data are garbage or not, just that you went through the exercise of searching, and dutifully followed the process described in the MEDDEV.

I guess this might eventually change under the MDR (even if justification is not required), but I"m not holding my breath. I'm more inclined to want to justify excluding some databases. I didn't have much trouble persuading a Class III premarket review team at one of the big NBs that searching MAUDE was a waste of time. I may have put it in slightly different language, though. :D

If left to my own devices (no pun intended), I would probably exclude pretty much all of the postmarket data that are available in publications and regulatory reporting databases, based on the poor quality of the available sources.
 

ASteel

Starting to get Involved
#5
We search databases that are available in countries we have distributed to: MAUDE (US), TGA DAEN (Australia), HPRA (Ireland), MHRA (UK), Reidar (Sweden & Nordic Countries), HC (Canada), etc. This is performed monthly and a yearly summary is included within our PMS report.
 
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