Reclassification after a substantial modification (Article 25)
Article 25(1) makes the deployer a provider in three cases, all involving high risk: if it puts its name or trademark on a high-risk system already placed on the market or put into service, without prejudice to contractual arrangements stipulating that the obligations are otherwise allocated; if it makes a substantial modification to it in such a way that it remains high-risk; or if it modifies the intended purpose of a system that was not high-risk in such a way that it becomes high-risk. If any of them applies, the system's classification should be re-run (an Alethexis methodological step) and the organisation should assess whether it becomes subject to the provider's obligations under Article 16. The obligations of Article 16 apply from 2 December 2027 for Annex III high-risk systems and from 2 August 2028 for Annex I ones; they do not reach the products in Annex I, Section B (Article 113, third paragraph, point (c), and Article 2(2), as amended by Regulation (EU) 2026/1744).