Establish and Maintain Post-Market Monitoring for High-Risk AI

Sub-obligations

These are independently assessable parts of the parent requirement.

1. Article 72(2)

   Upcoming

   Systematically Collect, Document and Analyse High-Risk AI Post-Market Performance Data

   Tracker Guidance

   Actively and systematically collect, document and analyse relevant deployer and other performance data throughout the high-risk AI system's lifetime so continuing compliance can be evaluated, including interaction with other AI systems where relevant. Do not treat sensitive operational data of law-enforcement deployers as part of this post-market monitoring data collection.

   Official text

   2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data which may be provided by deployers or which may be collected through other sources on the performance of high-risk AI systems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Chapter III, Section 2. Where relevant, post-market monitoring shall include an analysis of the interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are law-enforcement authorities.

2. Article 72(3)-(4)

   Upcoming

   Maintain the High-Risk AI Post-Market Monitoring Plan in Technical Documentation

   Tracker Guidance

   Base post-market monitoring on a documented plan that forms part of the technical documentation. For high-risk AI systems covered by Union harmonisation legislation listed in Annex I, Section A, where an existing post-market monitoring system and plan already apply, integrate the AI Act elements into those arrangements where appropriate, provided an equivalent level of protection is achieved. The same integration approach applies to Annex III point 5 systems placed on the market or put into service by financial institutions subject to relevant Union financial-services governance requirements.

   Official text

   3. The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring plan shall be part of the technical documentation referred to in Annex IV. The Commission, taking utmost account of the opinion of the Board, shall adopt guidance, including a template, on the post-market monitoring plan by 2 September 2027. 4. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where a post-market monitoring system and plan are already established under that legislation, in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems and plans already existing under that legislation, provided that it achieves an equivalent level of protection. The first subparagraph of this paragraph shall also apply to high-risk AI systems referred to in point 5 of Annex III placed on the market or put into service by financial institutions that are subject to requirements under Union financial services law regarding their internal governance, arrangements or processes.