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Article 61

Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems

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

2. In order to allow the provider to evaluate the compliance of AI systems with the requirements set out in Title III, Chapter 2 throughout their life cycle, the post-market monitoring system shall collect, document and analyse relevant data, which may be provided by users or which may be collected through other sources on the performance of high-risk AI systems. This obligation shall not cover sensitive operational data of users of AI systems 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.

4. For high-risk AI systems covered by the legal acts referred to in Annex II, Section A, where a post-market monitoring system and plan is already established under that legislation, the post-market monitoring documentation as prepared under that legislation shall be deemed sufficient, provided that the template referred to paragraph 3 is used.

The first subparagraph shall also apply 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 regarding their internal governance, arrangements or processes under Union financial services legislation.

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