CLAIM-2026-09-01-05
In AI Act Annex I, Regulation (EU) 2023/1230 on machinery is item 21 of Section B, while Regulation (EU) 2017/746 on in vitro diagnostic medical devices is item 12 of Section A.
Why it matters
Same driver, same agent, two different regimes: the device decides which one you are in, so classification has to happen before integration.
Sources
- euaiactexpl2026annex