A process to verify that a high-risk AI system meets all requirements of the AI Act before it can be placed on the EU market. Specified in Article 43.
5 questions answered with specific EU AI Act article references. 98 days until the August 2, 2026 enforcement deadline.
Not sure if your AI system is affected? Take the 5-minute diagnostic.A process to verify that a high-risk AI system meets all requirements of the AI Act before it can be placed on the EU market. Specified in Article 43.
For most Annex III high-risk systems, yes — internal conformity assessment under Annex VI is sufficient. For biometric identification systems (Annex III point 1), third-party assessment by a notified body is required (Article 43(1)).
The AI Act doesn't specify a timeframe. Industry estimates range from 3-12 months depending on system complexity, documentation readiness, and whether a notified body is required.
Technical documentation per Article 11 and Annex IV: system description, design choices, training data, testing results, risk management records, human oversight measures, and accuracy/robustness metrics.
A formal statement by the provider that the AI system complies with the AI Act. Required by Article 47. Must include provider details, system identification, and references to harmonised standards applied.
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