Article 60 permits providers to test high-risk Annex III systems in real-world conditions before market placement, subject to specific safeguards. Before commencing, the provider registers the test in the EU database using Annex IX’s five information categories: a unique test identification number (assigned by the database), provider and deployer contact details, system description and intended purpose, a summary of the testing plan, and information on any suspension or termination.

The Article 60 regime applies when the system processes real inputs from, or produces outputs that affect, persons under real or near-real operational conditions. Internal testing on historical or synthetic data does not trigger the obligation. The AI System Assessor documents the threshold determination for each pilot deployment.

The real-world testing plan addresses objectives, duration, geographical scope, test subject demographics, data collection and retention, informed consent procedures, human oversight during testing, suspension/termination criteria, and serious incident reporting. Testing results feed into the risk assessment, fairness evaluation, and PMM baseline.

Key outputs

• Annex IX five-category registration before testing commences
• Article 60 threshold determination documented per pilot
• Real-world testing plan with safeguards and informed consent
• Module 10 AISDP evidence