Establish post-market monitoring and incident response: Which missing control is most direct?
Passing conformity assessment does not end obligations; recurring operational failures require post-market monitoring and incident response.
The question
Under the EU AI Act, assume all relevant duties apply. A manufacturer’s high-risk quality-control system completed conformity assessment and entered service. Its technical documentation, data governance, instructions, human oversight, accuracy, robustness, and cybersecurity controls are satisfied. Six months later, production changes create recurring false alerts, but the manufacturer has no process for collecting operational performance, investigating incidents, or updating risk controls. Which missing control is most direct?
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- Repeat conformity assessment.Conformity assessment addresses conformity at the relevant assessment stage, while the stated deficiency concerns continuing operational monitoring and response.
- Revise user instructions to explain how operators should handle false alerts.Updated instructions may help operators, but they do not establish the missing lifecycle process for performance collection, incident investigation, and control updates.
- Revalidate training data and document the results before changing operational controls.Data revalidation could investigate one cause, but it does not itself create the required continuing process for monitoring incidents and updating risks.
- Establish post-market monitoring and incident response. ✓This directly creates the missing process for collecting performance information, investigating incidents, and updating controls after deployment.
The trap
After deployment, operational failures point to monitoring and incident response, not automatically to repeating conformity assessment. How to remember it
Passing conformity assessment does not end obligations; recurring operational failures require post-market monitoring and incident response.
How many of these would you get right?
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