EU_AI_ACT_ART16_PROVIDER_OBLIGATIONS_001

rules/regulations/eu/eu_ai_act_article16_provider_obligations.yaml

Citation

Regulation (EU) 2024/1689, Article 16 (Obligations of providers of high-risk AI systems): 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; (b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted; (c) have a quality management system in place which complies with Article 17; (d) keep the documentation referred to in Article 18; (e) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19; (f) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service; (g) draw up an EU declaration of conformity in accordance with Article 47; (h) affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48; (i) comply with the registration obligations referred to in Article 49(1); (j) take the necessary corrective actions and provide information as required in Article 20; (k) 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; (l) ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.

Condition

Establishes the comprehensive obligations of providers of high-risk AI systems: compliance with Section 2 requirements, identification on the product, quality management system, documentation, log retention, conformity assessment, EU declaration of conformity, CE marking, registration, corrective actions, demonstrating conformity on request, and accessibility compliance. Article 16.

Layer 1 detects

"place", "placing", "sell", "deploy", "launch" or "release" (and longer forms) followed by "high-risk AI" or "AI system", then "on the EU market", "on EU market", "in the Union" or "in Union", then "without" or "lacking", then "CE marking", "conformity assessment", "EU declaration" or "registration"; "no", "without", "skip", "skipping", "bypass" or "omit" (and longer forms) followed by "CE marking", "conformity assessment", "EU declaration of conformity", "quality management system", "QMS", "provider registration" or "EU database registration"; "high-risk AI" or "AI system" (singular) followed by "without", "lacking" or "missing" and then "provider name", "provider identification", "provider contact", "CE mark" (and longer forms), "conformity assessment", "conformity declaration" or "quality management"; "Article 16", "Art 16", "Art. 16" or "provider obligation" followed by "not met", "ignored", "skipped", "bypass" or "circumvent" (and longer forms); "no", "without", "skip" or "bypass" (and longer forms) followed by "Article 43", "Art 43" or "Art. 43" and then "conformity assessment"; and "provide" or "providing" followed by "high-risk AI", then "without" or "lacking", then "Annex IV", "technical documentation" or "EU declaration". "High-risk" may also be written "high risk". Case is ignored, the words must follow each other with no other word between them unless stated, and a phrase can start inside a longer word. It matches wording, not meaning: it misses the practice told in other words ("Launch the CV screening product in Germany next month and do the conformity assessment afterwards."), it does not check that the system is high-risk (any "AI system" counts, and the "no conformity assessment" forms need no AI system at all), and it fires on text that only names the practice, such as a refusal. Whether a text does the practice is judged in Layer 2.

Condition type

regex; semantic condition in the file, not run by the engine

Status in the file

approved