Article 16 · Chapter III: High-Risk AI Systems
Obligations of Providers of High-Risk AI Systems
High risk
Summary
The master checklist for providers: ensure compliance with Articles 9–15, indicate name and contact details on the system, operate a quality management system, keep documentation and logs, undergo conformity assessment, draw up the EU declaration of conformity, affix CE marking, register in the EU database, and take corrective action when required.
Key obligations
- Implement a quality management system (Art. 17)
- Keep documentation and logs (Arts. 18, 19)
- Run conformity assessment (Art. 43) and CE-mark (Art. 48)
- Register the system in the EU database (Art. 49)
- Take corrective action and notify (Arts. 20, 73)
Related articles
- Art 17Quality Management System
- Art 18Documentation Keeping
- Art 19Automatically Generated Logs
- Art 20Corrective Actions and Duty of Information
- Art 21Cooperation with Competent Authorities
- Art 43Conformity Assessment
- Art 47EU Declaration of Conformity
- Art 48CE Marking
- Art 49Registration
- Art 72Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems
- Art 73Reporting of Serious Incidents