They're not very prescriptive about how to put the UDI, whether adhesive labels or laser etching or something else. So I don't know any reason you couldn't do it that way if you want to. It does make the process a little more complicated, to make sure the UDI carrier encodes the same production date and serial number that are shown on the other label.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 21-May-2019 10:53
From: Eric Caus
Subject: UDI carrier on separate label allowed?
Dear forum,
is it allowed to fix a separate label with (only) the UDI carrier on the device? So UDI would not be not on the same device label with all other required info (like manufacturer, production date, part number, serial number, CE mark,...)
For the EU MDR?
And for the FDA?
Thank you
kind regards
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Eric Caus
Regulatory Officer
Kortrijk
Belgium
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