Regulation
When a software update makes you a new manufacturer — and when it doesn't.
Article 18 of Regulation (EU) 2023/1230 will make anyone who substantially modifies a machine its manufacturer — new conformity assessment, new risk assessment, new technical documentation, new declaration of conformity, new CE mark. Article 3(16) says the modification can be digital. It then gates that on two mechanical outcomes, and whether a machine-learning model update clears them is not settled by the instrument, its recitals, or the Blue Guide. What is settled is the exit: an update the original risk assessment already foresaw is not a substantial modification at all.
