EU AI Act, Article 72

Post-market monitoring

Unit OH-43 in the Assurance theme. The held citation is EU AI Act, Article 72, and the row asks for 3 pieces of evidence.

At a glance

Ref: OH-43
Theme: Assurance
Held source: EU AI Act
Citation: EU AI Act, Article 72
Evidence: 3 items
Gaps: 2 common

Evidence to keep

Post-market monitoringThe documented post-market monitoring system
Post-market monitoringThe monitoring plan within the technical documentation
Post-market monitoringCollected performance data and the analysis

Questions before you sign

Does the plan collect operator observations?
Who analyses them?
What change did the last cycle produce?

The requirement, in our words

Providers must set up and document a system for monitoring the system after it is placed on the market, proportionate to the technology and the risks, collecting and analysing performance data throughout the lifetime, including data supplied by deployers, and use it to evaluate compliance.

What it means for human oversight

Post-market monitoring is the feedback loop from the operator to the provider. The overseer's observations, refusals and near misses are the most valuable data the provider gets.

How to evidence it

Attach the artefacts above to the Post-market monitoring row with the system name, the owner and the date. The first one is the anchor: The documented post-market monitoring system. The OH-43 file is complete when the named person can produce that artefact and explain the decision it records, without asking someone else where it is.

The reviewer will sample one live decision and ask for The monitoring plan within the technical documentation. If that artefact for OH-43 cannot be produced, the row is a gap, whatever the policy says.

OH-43 carries 3 evidence items and 2 common gaps. For post-market monitoring, the evidence is a dated record that the control operated, not a statement that it exists in a policy. The OH-43 statement above is ours, written from EU AI Act, Article 72, not a reproduction of the licensed text.

Common gaps

Monitoring reduced to availability and error rate
No route for deployer-supplied data

Where the FDIS fits. The public abstract says the draft applies to all types of organizations across the AI system life cycle, so post-market monitoring is one of the places the guidance is expected to operate. For OH-43, the FDIS clause numbering and wording are not public, so this page cites EU AI Act, Article 72 above and does not quote the draft.

Related units

Source for this page: EU AI Act, Article 72. Open EU AI Act, Article 72 and compare it with the OH-43 statement above. Retrieved 2026-10-21.