Risk-Based Model

The regulation adopts a proportionate approach based on the level of risk that different AI applications may pose to citizens’ rights or to society.

• Unacceptable-risk systems are strictly prohibited, such as those involving subliminal manipulative techniques or social scoring by public authorities.
• High-risk systems, used in sensitive areas including health, education, justice or the management of critical infrastructure, are subject to stringent requirements, including conformity assessment, risk management, technical documentation, human oversight and continuous monitoring.
• Limited-risk systems must comply with transparency obligations, such as clearly informing users when they are interacting with an AI system.
• Minimal-risk systems can be developed and used freely, without specific regulatory requirements.

In addition to this risk-based categorisation, the regulation introduces specific rules for general-purpose AI models, including documentation obligations, systemic risk assessment, and dedicated safety measures for the most advanced models.

To support the proper application of the Artificial Intelligence Regulation (AI Act), the European Commission has published Guidelines on the Definition of an AI system. These guidelines clarify the scope of the Regulation and help organisations, public authorities and economic operators to interpret the criteria set out in it. The aim of these guidelines is to ensure the rules are applied consistently across the European Union while also fostering innovation and maintaining high levels of protection for health, safety and fundamental rights.

Additionally, to help providers and authorities determine the risk level of each system and the applicable requirements in a harmonised manner, the Commission has published guidelines on prohibited artificial intelligence practices.

The General-Purpose AI Code of Practice has also been published to provide technical and organisational guidance to help operators of these models voluntarily comply with the Regulation's principles. Adoption of this code is encouraged as a preparatory measure ahead of the full implementation of legal obligations, providing businesses involved in developing and deploying advanced AI models with greater predictability and legal certainty.

Furthermore, the European Commission, via the European AI Office, has developed a suite of support tools to facilitate the implementation of the AI Act. These tools are crucial for ensuring the consistent application of the Regulation throughout the European Union. This support framework includes technical guidance, interpretative documents and compliance support tools, as well as coordination with European standardisation organisations (CEN/CENELEC) in developing harmonised standards.