§ EU AI Act · Article 16

AI Act Article 16: Obligations, Deadlines & Penalties

Regulation (EU) 2024/1689, Article 16 · All obligations · EU AI Act · Full article analysis
At a glance
Article 16 of the AI Act imposes 12 obligations on provider. At least one obligation carries an explicit compliance deadline.
§ Obligations

All obligations under Article 16

Obligation 1
Ensure that high-risk AI systems are compliant with the requirements set out in Section 2. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
ensure
Deadline
Penalty
Obligation 2
Indicate on the high-risk AI system, its packaging, or accompanying documentation their name, registered trade name or mark, and contact address. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
indicate
Deadline
Penalty
Obligation 3
Have a quality management system in place which complies with Article 17. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
have
Deadline
Penalty
Obligation 4
Keep the documentation referred to in Article 18. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
keep
Deadline
Penalty
Obligation 5
When under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
keep
Deadline
Penalty
Obligation 6
Ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43 prior to being placed on the market or put into service. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
ensure
Deadline
prior to being placed on the market or put into service
Penalty
Obligation 7
Draw up an EU declaration of conformity in accordance with Article 47. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
draw up
Deadline
Penalty
Obligation 8
Affix the CE marking to the high-risk AI system, its packaging, or accompanying documentation to indicate conformity with this Regulation, in accordance with Article 48. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
affix
Deadline
Penalty
Obligation 9
Comply with the registration obligations referred to in Article 49 (1). Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
comply
Deadline
Penalty
Obligation 10
Take the necessary corrective actions and provide information as required in Article 20. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
take
Deadline
Penalty
Obligation 11
Upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
demonstrate
Deadline
upon a reasoned request
Penalty
Obligation 12
Ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882. Regulation (EU) 2024/1689, Article 16, Article 16
Obligated entity
provider
Action required
ensure
Deadline
Penalty
§ Deadlines

EU AI Act compliance deadlines

§ Frequently asked

Questions about Article 16

Who must comply with Article 16 of the AI Act? +
provider.
What does Article 16 of the AI Act require? +
ensure indicate have
What is the compliance deadline for AI Act Article 16? +
prior to being placed on the market or put into service; upon a reasoned request
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