AI Act Post-Market Monitoring
Ongoing, documented monitoring of a high-risk AI system's performance after it is placed on the market.
Definition
Article 72 requires providers of high-risk AI systems to establish and document a post-market monitoring system proportionate to the nature of the AI technologies and the risks. The plan must actively and systematically collect, document, and analyse relevant data throughout the lifetime of the system to evaluate continuous compliance.What this means in practice
For MedTech, the AI Act PMM plan should be integrated with the MDR/IVDR post-market surveillance plan and the PMCF/PMPF where required. Drift metrics, calibration checks, and real-world performance thresholds belong in both plans, not as parallel programmes.- •Running two disconnected post-market programmes for the same device. Regulators expect one integrated view of performance.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsAI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III.
Proactive collection of clinical data on a CE-marked device to confirm safety and performance.
Activities to monitor device safety and performance after market release.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2024/1689, Article 72VerifiedEUR-Lexeur-lex.europa.eu
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.