Article 61 - Post Market Monitoring System (ART61)

Article 61 requires:
  • Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the artificial intelligence technologies and the risks of the high-risk AI system.
  • The post-market monitoring system shall actively and systematically collect, document and analyse relevant data provided by users or collected through other sources on the performance of high-risk AI systems throughout their lifetime, and allow the provider to evaluate the continuous compliance of AI systems with the requirements set out in Title III, Chapter 2 (Article 09-15).
  • 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 (Article 11). 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.
  • For high-risk AI systems covered by the existing legal acts, where a post-market monitoring system and plan is already established under that legislation, the elements described in paragraphs 1, 2 and 3 shall be integrated into that system and plan as appropriate.
    These requirements also apply to high-risk AI systems placed on the market or put into service by credit institutions, to evaluate the creditworthiness of natural person or establish credit score, regulated by Directive 2013/36/EU.
Below is the list of controls/checks part of Article 61.