High-risk § I

The Artificial Intelligence Act (the ‘AI Act’), which entered into force on 1 August 2024, lays ¹ down harmonised rules for the placing on the market, putting into service, and use of artificial intelligence (‘AI’) in the Union². That regulation aims to promote innovation in and the uptake of AI, while ensuring a high level of protection of health, safety,and fundamental rights in the Union, including democracy and the rule of law. The AI Act follows a risk-based approach, classifying AI systems into different risk categories depending on the risks they pose to health, safety and fundamental rights.

One of those categories is high-risk AI systems, classified as such in accordance with Article 6 AI Act, read in conjunction with Annexes I and III AI Act. Chapter III AI Act imposes a set of requirements and obligations on providers and deployers of high-risk AI systems to ensure that they are trustworthy, safe to use, and respect fundamental rights. The scope of the use cases falling within this high-risk category is limited and proportionate, covering only those AI systems that pose a significant risk of harm to health and safety, or an adverse impact on fundamental rights.

These Guidelines are issued pursuant to Article 6(5) AI Act. They aim to support providers and deployers of AI systems, as well as competent market surveillance authorities, in assessing whether an AI system should be classified as high-risk, thereby facilitating the uniform application and effective enforcement of Article 6 AI Act. The Guidelines set out the Commission’s interpretation of certain concepts that are relevant for classification purposes and, in accordance with Article 6(5) AI Act, contain practical examples of AI systems that should or should not be classified as high-risk. The examples listed in these Guidelines strive to cover all areas and use cases, but theyare not to be considered as exhaustive and may be updated over time.They only aim to clarify which types of AI systems may or may not be classified as high-risk under Article 6 AI Act. The fact that an AI system is listed as an example in these Guidelines does not necessarily mean that it s use should automatically be considered to be lawful, since such use would still need to comply with other applicable legislation.

The scope of these Guidelines is limited only to high-risk classification whether an AI system is high-risk or not. The Guidelines will be complemented in the future with other Commission guidelines aimed to facilitate compliance with the requirements for high-risk AI systems and the obligations for providers and deployers.

These Guidelines take into account the outcome of a stakeholder consultation and input provided by the Member States in the context of the European Artificial Intelligence Board (‘AI Board’). The draft will be further consulted with the AI Board and published for additional stakeholder feedback before the Guidelines are adopted by the Commission.

The Guidelines are not binding. Any authoritative interpretation of the AI Act may ultimately only be given by the Court of Justice of the European Union (‘CJEU’).