Hello Anon,
It depends on if the versions of software are still available in the market or if gets replaced with each subsequent version. If multiple versions of the software are available in the market, i.e. version 1.1 on hardware X and version 1.3 on hardware Y, then all applicable UDI's should be visible on EUDAMED - and more importantly to the users. If version 1.1 gets replaced by version 1.2 gets replaced by version 1.3 in a cloud application where the user is only using most current version, than most likely only the latest UDI/version would need to be available. Proper configuration management and version control needs to be applied to the lifecycle of the software which has impact on many other aspects of placing product on the market.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 28-Feb-2024 11:15
From: Anonymous Member
Subject: Software versions in EUDAMED
This message was posted by a user wishing to remain anonymous
Dear RAPS!
Should each version of the software that has its own UDI-DI be visible in the EUDAMED, or only the latest software version? E.g. version 1.1 had its own UDI-DI and then was upgraded to version 1.2 - which didn't require new UDI-DI, and then the next version 1.3- new UDI-DI was needed. In this case, should both versions, 1.1 and 1.3, be visible in the EUDAMED or only 1.3 as the latest upgrade?