How is a high-risk AI system identified?
Classification starts with Article 6: paragraph 1 covers products and safety components linked to Annex I; paragraph 2 refers to the uses in Annex III. Subsequent paragraphs set out conditions, exceptions and documentation duties. Articles 8 to 15 establish requirements for high-risk systems.
Editorial orientation: read the linked provisions for conditions, exceptions and obligations.
Consolidated edition: 27 July 2026
The provisions to read
Article 6Classification rules for high-risk AI systems
1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be…
Compliance with the requirements
1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI…
Risk management system
1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems. 2. The risk management system shall be understood as a continuou…
Data and data governance
1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the…
Technical documentation
1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date. That technical document…
Record-keeping
1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system. 2. In order to ensure a level of traceability of the functioning…
Transparency and provision of information to deployers
1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use…
Human oversight
1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons duri…
Accuracy, robustness and cybersecurity
1. High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and cybersecurity, and that they perform consistently in…
List of Union harmonisation legislation
Section A. List of Union harmonisation legislation based on the New Legislative Framework 2. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety…
High-risk AI systems referred to in Article 6(2)
High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas: 1. Biometrics, in so far as their use is permitted under relevant Union or national law…
Technical documentation referred to in Article 11(1)
The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to the relevant AI system: 1. A general description of the AI system…