Hello Anon,
In general, additional components like laptops, desktop computers, printers, monitors, tablets, and even smart phones - the hardware - are not considered part of the "system". There should be specifications or minimum requirements for the software application to work on the computer. Most regulatory agencies take this approach unless based on the system, risk of the device, how the software is used with the hardware platform, the computer hardware (itself being a standard "off the shelf" computer) would not be considered regulated. Therefore, it would not need a Unique Device Identification (UDI). This is especially true if the software and sensor can be used with any laptop computer which meets the minimum specifications. You are correct, it would be a nightmare to update a UDI on every computer or laptop your users might have and update along with the software version.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 14-Feb-2024 07:02
From: Anonymous Member
Subject: UDI for hardware running software
This message was posted by a user wishing to remain anonymous
Hello all!
Our product consists of software, a sensor, and a laptop computer. The UDI lives on the About page of the software. It is updated according to the software version.
My question is about the computer. Does the UDI also have to appear on the hardware? If so, how is the updating managed? Every time the software is updated, the label on the computer would have to be changed? Very burdensome!
Thanks for the collective wisdom!