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Article 3: Definitions

EU Official:
Title I: General Provisions

According to Article 3, an AI system is a machine-based system designed to operate with varying levels of autonomy, that may exhibit adaptiveness, and infers from input how to generate outputs such as predictions, recommendations or decisions.

Official text

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

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Official guidance

PublishedPublished 6 Feb 2025

Guidelines on the definition of an AI system

The European Commission clarifies when a system qualifies as an 'AI system' under the AI Act. The guidelines emphasize that the system must be machine-based, operate with some degree of autonomy, and generate outputs that influence physical or virtual environments. Traditional software, simple rule-based systems and basic statistical methods generally fall outside the definition.

▶Key points (6)
  • •An AI system must be machine-based and operate with some degree of autonomy
  • •Systems requiring full manual human involvement are excluded
  • •Simple rule-based systems (if-then) are not covered
  • •A system requiring human input can still be AI if it independently generates outputs
  • •The definition is technology-neutral, covering machine learning, logic-based and statistical approaches
  • •Expert systems delegating process automation may qualify as AI
Official document (EN)→EC source page→

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Frequently asked questions

How does Article 3 AI Act define an AI system?+
According to Article 3, an AI system is a machine-based system designed to operate with varying levels of autonomy, that may exhibit adaptiveness, and infers from input how to generate outputs such as predictions, recommendations or decisions.
What is a provider under the AI Act?+
Article 3(3) defines a provider as a person or organisation that develops an AI system or general-purpose AI model and places it on the market or puts it into service under its own name or trademark.
What is a deployer under Article 3 of the AI Act?+
Article 3(4) defines a deployer as a person or organisation using an AI system under its authority, except where the AI system is used in the course of a personal non-professional activity.
Do SMEs also need to comply with Article 3 of the AI Act?+
Article 3 of the AI Act does not provide a general exemption for SMEs. However, the AI Act includes supportive measures and potentially lighter obligations for small and medium-sized enterprises, depending on their role in the AI value chain.
How does Article 3 of the AI Act relate to the GDPR?+
Article 3 of the AI Act complements the GDPR. While the GDPR protects personal data, the AI Act focuses on the safety and trustworthiness of AI systems. Organisations must comply with both regulations when their AI system processes personal data.
What are the deadlines for Article 3 of the AI Act?+
The AI Act follows a phased implementation. Prohibited AI practices apply from February 2025, obligations for high-risk AI systems from August 2026, and other provisions take effect gradually. The specific deadline for Article 3 depends on the category of the obligation.
Does Article 3 of the AI Act also apply to AI systems I purchase?+
Yes, Article 3 of the AI Act may also be relevant when you purchase AI systems. As a deployer, you have your own obligations under the AI Act, regardless of whether you developed the system yourself or purchased it from a provider.
What is the difference between provider and deployer under Article 3 of the AI Act?+
Under Article 3 of the AI Act, the provider is the entity that develops or places the AI system on the market, while the deployer is the entity that uses the system under its own authority. Both roles carry different obligations.