Supporting the implementation of the AI Act with clear guidelines

The AI Office is preparing guidelines to ensure a smooth implementation of the AI Act.

In the context of the implementation of the AI Act and the proposed Digital Omnibus, the Commission is advancing work on a set of initiatives designed to support compliance with the rules and meet the needs expressed by stakeholders. The AI Office is currently preparing a set of guidelines to provide clear and practical instructions on how to apply the AI Act, alongside other relevant EU legislation.

In the course of 2026, the Commission will develop:

• Guidelines on the practical application of the high-risk classification
• Guidelines on the practical application of the transparency requirements under Article 50 AI Act
• Guidance on the reporting of serious incidents by providers of high-risk AI systems
• Guidelines on the practical application of the high-risk requirements
• Guidelines on the practical application of the obligations for providers and deployers of high-risk AI systems
• Guidelines with a template for the fundamental rights impact assessment
• Guidelines on the practical application of rules for responsibilities along the AI value chain
• Guidelines on the practical application of the provisions related to substantial modification
• Guidelines providing a voluntary template for the post-market monitoring of high-risk AI systems
• Guidelines on the elements of the quality management system which SMEs and SMCs may comply with in a simplified manner
• Guidelines on the AI Act's interplay with other EU legislation, for example the joint guidelines of the Commission and European Data Protection Board on the interplay of the AI Act and EU data protection law

Stakeholders have asked for clearer guidance on how the AI Act's research exemptions in Article 2(6) and (8) should be applied in practice, especially in specific areas such as pre-clinical research and product development for medicines and medical devices. The Commission will make this a priority. These simplification efforts will ensure that the AI Act is implemented smoothly and predictably, supports innovation, and helps Europe strengthen its leadership in safe, AI-driven development.

Stakeholders can also get support from the AI Act Service Desk and find useful information on the AI Act Single Information Platform.

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