Label Printing: Medical Device related UDI Requirements - GUDID Aspects

Pmarszal

Pmarszal

Involved In Discussions
Hello,

We are currently printing our own product labels which include the UDI barcode. Our product is identified by a serial number and expiration date that is included in the UDI barcode and also includes the device identifier.

We are looking for a third party to print labels for us. If we are assigning the DI and PI and verifying it in-house 100%, does the third party company need to be registered as a labeler in GUDID?

I am confused if the labeler need to be registered with GUDID just because they print the label, or enter the information into the GUDID system.

Thanks in advance.
 
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