Instructions for Use Guidance (Art. 26(4)) The deployer’s Article 26 monitoring obligation is only as effective as the guidance the provider supplies. The Instructions for Use must include sufficient operational monitoring guidance for the deployer to fulfil their obligation. This guidance specifies the minimum monitoring activities: reviewing system outputs for consistency and plausibility, tracking human oversight metrics, monitoring complaint and appeal rates, and observing the system’s behaviour for changes indicating degradation or drift. The Instructions also define minimum data that the deployer must collect and share with the provider: aggregated performance statistics, anonymised output samples, human oversight metrics (override rates, review times), and a complaint and incident summary. The Legal and Regulatory Advisor formalises these data-sharing requirements in the deployment contract. Clear suspension criteria are also provided. Article 26(5) requires deployers to suspend use when they consider the system presents a risk, but deployers may lack the technical knowledge to assess risk. The Instructions specify observable indicators that should trigger suspension: systematically biased output patterns, sudden output distribution changes, error rates exceeding defined thresholds, and use outside the documented intended purpose. Key outputs

• Deployer monitoring guidance in Instructions for Use
• Minimum data-sharing requirements formalised in contract
• Suspension criteria with observable indicators
• Module 8 and Module 11 AISDP evidence