Anon,
The Unique Device Identification (UDI) should always be viewed from the user perspective. If the company name on the device changes, then this could be perceived as different labelling and different to the user, so probably needs a new UDI. If the address changes on the device labelling, again this could be perceived as different labelling to the user, so probably needs a new UDI. There are many implications to changing test and content of a labelling which may or may not impact the UDI. You might want to seek some expert advice to specifically look at the two versions of labelling to determine if there is a new UDI needed. Off the top of my head, because the change to content of labelling would be seen differently to the user - a new UDI would probably be advised.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 09-Dec-2023 10:22
From: Anne LeBlanc
Subject: Company Name Change affect on UDI
Hello Anon
If it's still the same company, then the UDI can generally stay the same. You'll need to get the name and/or address updated in the UDI database(s), registration(s), and UDI issuing agency.
If the product is being transferred to a different company, the UDI may still stay the same, though that situation is a bit more complicated.
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Anne LeBlanc
United States
Original Message:
Sent: 07-Dec-2023 12:37
From: Anonymous Member
Subject: Company Name Change affect on UDI
This message was posted by a user wishing to remain anonymous
If the corporate name changes on a device, is a new UDI required to be assigned? (no other changes- same product, contact info, etc.)
If an address changes on a device, is a new UDI required to be assigned? (no other changes, except maybe name but same product, packaging, etc.)