Article 16

Obligations of providers of high-risk AI systems

High riskApplicable from August 2, 2026
Applies to: Provider

Article 16 consolidates what providers of high-risk AI systems must do before and after placing a system on the market.

Key points

  • Ensure the system meets all Chapter III requirements
  • Operate a quality management system and keep documentation and logs
  • Carry out conformity assessment, draw up the declaration, affix CE marking
  • Register the system in the EU database and take corrective action when needed
  • Indicate name and contact details and cooperate with competent authorities

This page is a plain-language summary for orientation only. It is not legal advice — the binding text is Regulation (EU) 2024/1689.

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