Article 8 is the gateway: high-risk AI systems must comply with the requirements in Section 2, taking account of the system's intended purpose and the state of the art. For product-regulated systems, the AI Act requirements can be integrated with existing product documentation and testing where the product is also covered by Union harmonisation legislation.
Article 16 then turns those requirements into provider obligations. A provider must ensure Section 2 compliance, identify itself on the system or accompanying documentation, maintain a quality management system, keep required documentation and logs where under its control, complete the relevant conformity assessment, draw up the EU declaration of conformity, affix CE marking where required, register where Article 49 applies, take corrective action, demonstrate conformity to competent authorities, and comply with applicable accessibility requirements.
Under amended Article 111(2), the high-risk operator rules apply to a system placed on the market or put into service before its Chapter III application date only if the system undergoes significant design changes from that date. The controlling date is 2 December 2027 for an Article 6(2) Annex III system and 2 August 2028 for an Article 6(1) Annex I system. This transition rule uses a different test from the Article 43 substantial-modification rule that reopens conformity assessment, so record the first placement or service date, type and model, change description, and legal test instead of treating every software update alike.