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Labeling to Customer Requirements

JoCam

JoCam

Trusted Information Resource
#1
#1
Hi All,

Where does a medical device manufacturer stand when a customer asks them to permanently print information specific to their facility onto the device label or the device itself during manufacturing. Should the manufacturer just tell the customer to affix whatever labels they wish after they've purchased or fulfill their request, and if so does the associated technical file need to be amended, and worse case scenario for class II and above be resubmitted for CE mark.

Jo
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
JoCam said:
Should the manufacturer just tell the customer to affix whatever labels they wish after they've purchased or fulfill their request
Click to expand...
There's no regulatory "shall" (or "should") here. It's a matter for commercial consideration as well as for risk management.
JoCam said:
does the associated technical file need to be amended
Click to expand...
Yes, if a decision is made to change the manufacturer's own specifications/processes.
JoCam said:
worse case scenario for class II and above be resubmitted for CE mark.
Click to expand...
It depends on the specifics and should go through an orderly documented analysis.
 
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