New Guidelines Support Companies in Complying with EU Rules on High-Risk Artificial Intelligence Systems

Jan 1, 2026 | Actualidad, Current affairs, Featured, Interview, Portada, Post, Revista Lloseta, Thursday Daily Bulletin, Tradition

Companies developing high-risk artificial intelligence systems now have access to new practical guidance to help them comply with the European Artificial Intelligence Act (AI Act). A set of support manuals has been published by the Spanish Agency for Artificial Intelligence Supervision (AESIA) to assist businesses in meeting regulatory requirements before bringing AI systems to market.

The release of these guidelines was announced during a meeting of the International Advisory Council on Artificial Intelligence, highlighting the collaborative work carried out with twelve Spanish companies from different sectors. These firms participated in a controlled testing environment designed to analyse, test and apply the European AI regulation in real-world conditions.

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New Guidelines Support Companies in Complying with EU Rules on High-Risk Artificial Intelligence Systems

The documents stem from the AI Sandbox, a pioneering initiative that enables SMEs, start-ups and large companies to experiment with high-risk AI systems under expert guidance and regulatory supervision. The initiative aims to promote responsible innovation, ensuring compliance with EU rules while safeguarding fundamental rights.

The published material includes two explanatory guides to improve understanding of the regulation and thirteen technical guides covering key areas such as risk management, data governance, transparency, human oversight and cybersecurity. These are complemented by practical checklists designed to support companies in implementing quality management and governance frameworks.

The testing environment involved cooperation with supervisory authorities such as AESIA, the Spanish Data Protection Agency, the Bank of Spain and the Spanish Aviation Safety Agency, alongside a panel of specialised experts. The lessons learned from this process have been consolidated into the newly published guidelines.

While the guides are non-binding and do not replace future harmonised standards, they provide practical recommendations tailored to different types of organisations. The initiative has been recognised at European level as a best practice, strengthening legal certainty and enhancing the international competitiveness of Spanish companies in the AI sector.