Article 16 consolidates the full set of obligations that apply to providers of high-risk AI systems. It is a comprehensive checklist that providers must satisfy before and after placing a high-risk AI system on the EU market.
Provider Obligation Checklist
- Establish a quality management system (Article 17)
- Draw up and keep up-to-date technical documentation (Article 11 + Annex IV)
- Comply with logging requirements (Article 12)
- Conduct the appropriate conformity assessment (Article 43)
- Affix the CE marking (Article 48)
- Register the system in the EU database (Article 49)
- Take corrective actions for non-compliant systems and inform authorities and deployers
- Cooperate with national competent authorities upon request
- Appoint an authorised representative in the EU if the provider is established outside the EU
Quality Management System (Article 17)
Article 17 requires providers to put in place a quality management system (QMS) covering policies, procedures, and systematic actions to ensure and demonstrate compliance. The QMS must address: overall AI strategy; compliance checking and testing; technical documentation; data management; risk management; post-market monitoring; serious incident reporting; and staff AI literacy under Article 4.
Regulation (EU) 2024/1689 — Article 16
“Providers of high-risk AI systems shall: (a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2 of this Chapter; (b) indicate on the high-risk AI system or, where that is not possible, on its packaging or accompanying documentation, their name, registered trade name or registered trade mark, the address at which they can be contacted.”