MDR Adverse Events Assessments - What qualifications are required?

#1
Hi folks,
I'm wondering if anyone can help me find a reference that indicates that a medical background is required to enable an employee to assess if an adverse event is reportable to the FDA or other regulators?
We have this built into our system, but I can't locate the source of the requirement.
Obviously, the person would need to be competent in CFR803 and the other regulations for assessment of reporting and competent in the local QMS procedures, but do they require Medical training / background?
Really appreciate peoples thoughts.
Thanks
T
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
We have this built into our system, but I can't locate the source of the requirement.
I'm not aware of such an official requirement.

Naturally, it should only be a matter of clear definitions in the regulations, and where residual ambiguity persists, a matter of providing simple and practical guidance, if possible with examples. Unfortunately, I can't say that regulators always excel at that.
 

Watchcat

Trusted Information Resource
#3
A medical background may be needed (not "required") to determine whether the event met regulatory definitions like "serious" and "may have caused," but once those determination have been made, a medical background is not needed, nor is it required, to determine reportability under any regulations with which I am familiar. Definitely not required by FDA or under the MDD, don't know about the MDR.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
A medical background may be needed (not "required") to determine whether the event met regulatory definitions like "serious" and "may have caused,"
This is what I referred to - it should be possible (I don't dare say "easy") for any averagely intelligent person to make those determinations based solely on the definitions in the regulations, or at most with the aid of official guidance. As far as I can judge it is the case in most instances, but it's quite situation-specific and obviously I only got exposed to a finite range of such situations. Based on regulations and guidance known to me, I can definitely imagine cases where the call is not that straightforward, which leaves some to be desired in regard to existing guidance...
 
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