EU AI Act Article 19 — Conformity Assessment and Documentation
EU AI Act Article 19 conformity assessment requirements: technical documentation, self-assessment, notified body assessment, CE marking, and EU database registration.
EU AI Act Article 19 requires providers of high-risk AI systems to carry out a conformity assessment before placing the system on the EU market.
The conformity assessment verifies that the AI system meets all applicable requirements of the Act — including risk management, training data governance, technical documentation, logging, transparency, and human oversight.
Self-Assessment vs. Notified Body Assessment
For most high-risk AI systems, providers may conduct a self-assessment using the internal control procedure set out in Annex VI. For AI systems used in biometric identification and certain other high-risk categories, third-party conformity assessment by an accredited notified body is required.
Technical Documentation Requirements
The conformity assessment requires the technical file specified in Article 11 and Annex IV — covering system description, development methodology, training data information, performance metrics, risk management, monitoring plan, and all required test results.