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Article 16 of 11314%
Nederlands

Article 16: Obligations of providers of high-risk AI systems

Praxikon tracks Article 16 (Obligations of providers of high-risk AI systems) under the EU AI Act, citing the source for every statement.

EU Official:
UpcomingAnnex III from 2 Dec 2027; Annex I from 2 Aug 2028
Title III: High-Risk AI Systems

Article 16 requires providers to ensure their AI systems comply with requirements, implement a quality management system, maintain technical documentation, and affix the CE marking.

Official text

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Source: EUR-Lex, Regulation (EU) 2024/1689. Text reproduced verbatim.

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Related enforcement

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Cross-references

Articles

Art. 6Art. 9Art. 10Art. 11Art. 12Art. 13Art. 14Art. 15

Recitals

7879

Annexes

Annex 4

Frequently asked questions

What obligations do providers of high-risk AI have under Article 16?+
Article 16 requires providers to ensure their AI systems comply with requirements, implement a quality management system, maintain technical documentation, and affix the CE marking.
Must a provider register under Article 16 AI Act?+
Yes, providers must register themselves and their high-risk AI system in the EU database in accordance with Article 49, before placing the system on the market.
What documentation does Article 16 of the AI Act require?+
Article 16 of the AI Act requires that relevant documentation is maintained as part of the compliance process. This may include technical documentation, instructions for use, logs or declarations of conformity, depending on the classification of the AI system.
What must a provider do before placing a high-risk AI system on the market?+
Before market placement, the provider must: establish a risk management system (Art. 9), ensure data governance (Art. 10), prepare technical documentation (Annex IV), undergo a conformity assessment (Art. 43), affix the CE marking and register the system in the EU database (Art. 49).
What if I modify a third-party AI system and release it under my own name?+
If you substantially modify an AI system or place it on the market under your own name, you are considered a provider under the AI Act. You then bear all Article 16 obligations, including conformity assessment and technical documentation.
Do I need to set up a quality management system as a provider?+
Yes, Article 17 (referenced by Article 16) requires providers of high-risk AI to establish a quality management system (QMS). This includes strategies, procedures, rules and instructions for systematically ensuring compliance throughout the entire lifecycle.

What Article 16 requires in practice

Connections

What connects to Article 16 AI Act

Themes where this returns

The counterpart in the other law

GDPR interpretation that also applies here6 of 11