Chapter VIII
Article 72
Post-Market Monitoring Plan and Post-Market Monitoring System
Plain-Language Summary
Providers of high-risk AI systems must establish a post-market monitoring system and prepare a post-market monitoring plan. The plan must be part of the technical documentation and must cover the entire post-deployment lifecycle.
Keywords
post-market monitoringmonitoring planlifecycleperformancedata collectiontechnical documentation
Legal Text
Article 72 — Post-Market Monitoring Plan and Post-Market Monitoring System for High-Risk AI Systems 1. The post-market monitoring plan shall describe the method and procedure for collecting and processing data from deployers and other sources regarding the performance of high-risk AI systems throughout their lifetime. 2. The monitoring plan shall at minimum specify: (a) the intended purpose of the high-risk AI system; (b) post-market monitoring objectives with clear metrics; (c) the methods and procedures to collect and analyse data relevant to the objectives; (d) the period for monitoring and reporting; (e) measures to be taken in case risks are identified. 3. Providers shall continuously evaluate the effectiveness of their post-market monitoring system and update the monitoring plan accordingly.