UDI - Traceability of Products

A

acro14

#1
Dear forum members,

my company is a european manufacturer of medical devices. We want to prepare for the upcoming UDI implementation in Europe. In this context I have a question regarding traceability of products after market release: when we sell products to a wholesaler or retailer, e.g. a supermarket or medical supply store, how can traceability be assured? You maybe not know the end customer who bought a product. Are stores obliged to modify their registration systems to fit the UDI scheme?

How is this issue handled in the US? I will appreciate your replies.
 
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shimonv

Trusted Information Resource
#2
Hello acro14,
You need to be more specific with what you are doing and your questions so that forum members can reply.

I will just point out that UDI and tractability are two different things. They are related but the requirements and implementation are quit different.

Cheers,
Shimon
 
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