Article 72 requires providers of high-risk AI systems to establish, document, and implement a post-market monitoring (PMM) system. The PMM system must proactively collect and review data to monitor compliance throughout the system's operational lifetime.
- PMM must cover the entire operational lifetime of the high-risk AI system
- PMM data must be retained and made available to NCAs upon request
- Serious incidents detected through PMM must be reported to the NCA under Article 73
- PMM findings may trigger a need for substantial modification and re-assessment
- For Annex III systems, the PMM plan must be part of the technical documentation (Annex IV)
Regulation (EU) 2024/1689 — Article 72(1)
“Providers of high-risk AI systems 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.”