Article 61, Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems, Artificial Intelligence Act (Proposal 25.11.2022)
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.
Important note: This is not the final text of the Artificial Intelligence Act. This is the text of the proposal from the Council of the European Union (25.11.2022).
The Articles of the EU Artificial Intelligence Act, proposal from the Council of the European Union (25.11.2022):