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On 12 June 2024, a new era began in the regulation of artificial intelligence (“AI“) with the adoption and publication of the European Union’s Artificial Intelligence Regulation (“AI Act“). The purpose of the legislation is to provide a framework for the safe, transparent, and responsible development and use of AI in the European Union. In order to properly interpret the obligations set out in the AI Act, it is first necessary to clarify exactly which organizations, activities, or technological solutions are covered by the regulation.
In the second part of our series of articles, we will therefore examine the most important rules relating to the scope of the AI Act in order to help our clients start preparing for compliance in advance and to identify whether they are developing or using AI systems in their operations that are subject to the provisions of the AI Act.
The most important rules relating to the scope of the AI Act
Subject of the AI Act
The AI Act essentially covers the regulation of AI systems. Accordingly, it is first important to identify what qualifies as an AI system.
According to the AI Act, an AI system is a machine-based system that is specifically designed to operate with varying levels of autonomy and to be capable of adapting after deployment. These systems analyze inputs for explicit or implicit purposes and generate outputs—such as predictions, content, recommendations, or decisions—that may have an impact on the physical or virtual environment.
What fundamentally distinguishes AI systems from traditional software solutions is their ability to learn from input data, draw conclusions based on that data, and create models. In contrast, simpler software systems based on classic programming approaches—including systems that perform automated operations based solely on predefined, human-set rules—do not have such learning or adaptation capabilities. As a result, these solutions are not considered AI systems and are therefore not covered by the relevant regulations.
Traditional software solutions include applications that operate entirely on predetermined rules and are incapable of independent learning or adaptation. These include traditional calculators, certain basic functions of Microsoft Excel, and performance evaluation software used for financial forecasting, which are only capable of processing historical data and drawing simple statistical conclusions.
It is also important to note that, as a general rule, the AI Act does not apply to certain specific areas. The scope of the regulation does not cover AI systems used for military, defence, or national security purposes, nor does it cover systems, models, and results created specifically for scientific research and development. In addition, the AI Act does not apply to natural persons who use AI systems solely for personal, non-professional purposes.
Territorial and personal scope
The scope of the AI Act is not limited to operators located within the European Union. The regulation applies to all AI systems that are placed on the market, put into service, or used within the internal market of the European Union. Accordingly, in certain cases, the regulation also applies to operators located outside the Union.
The regulation essentially covers all operators who come into contact with AI systems, from development to use. Accordingly, the scope of the AI Regulation may include, among others, developers, service providers, distributors, importers, installers, operators, and users of the systems.
Temporal scope
The provisions of the AI Act will enter into force in stages.
However, it is important to note that certain provisions of the AI Act are already in force. These include, among others, provisions on definitions, rules on AI systems that pose an unacceptable risk (i.e., prohibited AI systems), obligations governing general-purpose AI models, and provisions on AI literacy, regulatory oversight, and sanctions.
The requirement for so-called AI literacy has particular significance. Under this provision, organizations using AI systems are required to ensure that the persons managing or operating the system have an adequate level of knowledge about AI.
According to the current provisions of the AI Act, the majority of the provisions will become applicable on 2 August 2026. However, as part of the Digital Omnibus Package, the European Commission proposed in November 2025 that the application of certain rules be postponed by up to 18 months.
Further uncertainty regarding implementation arises from the fact that the Commission was supposed to publish guidance on the classification of high-risk AI systems by 2 February 2026. These guidelines are key to determining whether a given AI application is considered high-risk and, as a result, subject to stricter documentation, compliance, and oversight requirements. However, the guidelines have not yet been published. In addition, several Member States have encountered difficulties in designating the authorities responsible for implementing the regulation.
As a result, there is still considerable uncertainty regarding the entry into force and practical application of certain provisions.
Domestic regulation
Due to its legislative form, Hungarian regulation is essentially supplementary to EU rules. Accordingly, Act LXXV of 2025 on the implementation of the European Union’s Artificial Intelligence Act in Hungary (“Hungarian AI Act”) applies only to matters, organizations, and AI systems that affect Hungary or its territory.
In terms of temporal scope, the AI Act generally applicable from December 2025, with the exception of the provision on the regulatory sandbox, which will enter into force on 2 August 2026.
Summary
The AI Act regulates systems that can learn from input data, drawing conclusions, or generating outputs autonomously, while traditional software that operates solely according to predefined rules is not covered by its scope. The territorial scope of the AI Act is broad, as it applies not only to entities established in the EU, but also to those who place AI systems on the EU market or use their outputs in the EU. The regulation covers all relevant actors, from the development to the use of the system. Although the rules of the AI Act become applicable in stages, several key provisions are already in force, but the lack of guidelines and institutional conditions for implementation is currently causing uncertainty in practical application.
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