CHAPTER IX

Article 72: Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

Plain English Summary

What this article does: Requires providers to establish and operate a post-market monitoring system. Who it applies to: Providers of high-risk AI systems. Key requirements: Para 1: Providers must establish and document a post-market monitoring system to actively and systematically collect, document, and analyse data on performance throughout the AI system's lifecycle. Para 2: The system must allow the provider to evaluate continuous compliance with the requirements and to identify measures needed. Para 3: Must be proportionate to the nature and risk of the AI system. Para 4: The post-market monitoring plan must be part of the technical documentation.

1. Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the AI technologies and the risks of the high-risk AI system.

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.

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 shall adopt an implementing act laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be included in the plan by 2 February

2026. That implementing act shall be adopted in accordance with the examination procedure referred to in (2).

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. SECTION 2 Sharing of information on serious incidents

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