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Traceability Requirements for Medical Device History Records (DHR's)

E

ElmerF

#1
Hi there,

I'm just looking for a regulation that governs tracebility for medical devices. Specifically my question is: Is it ok to use 2 lots of a component in a sub-assembly Lot History Record. In other words mix componentsbut record both lots numbers. This would mean should you need to trace the materials, you would need to investigate both components. Is this prohibited/ok and if so what is the regulation. I know I have seen this done in Med device LHRs in the past.

thanks,

Elmer
 

Michael Malis

Quite Involved in Discussions
#4
Hi there,

I'm just looking for a regulation that governs tracebility for medical devices. Specifically my question is: Is it ok to use 2 lots of a component in a sub-assembly Lot History Record. In other words mix componentsbut record both lots numbers. This would mean should you need to trace the materials, you would need to investigate both components. Is this prohibited/ok and if so what is the regulation. I know I have seen this done in Med device LHRs in the past.

thanks,

Elmer

Elmer,

I would record 2 separate sub-lots. This way, if you need to recall the product, you have the way to segregate materials and recall only 1 sub-lot. However, if the parts are already mixed, it is OK, but you will need to recall it all.

I hope this helps,
Mike
 
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