Spain’s New Guidance for High-Risk AI Compliance

Spain Issues Guidance Under the EU AI Act

In December 2025, the Spanish Agency for the Supervision of Artificial Intelligence (AESIA) published detailed guidance documents and templates aimed at helping providers and deployers of high-risk AI systems comply with the requirements of the EU AI Act. Currently, all materials are available in Spanish only.

Developed through Spain’s AI regulatory “sandbox” with input from industry, technical experts, and authorities, the guidance is non-binding and offers practical recommendations. AESIA emphasizes these documents are living resources, subject to regular updates to reflect evolving standards and European Commission guidelines. They will be updated if the Digital Omnibus amending the Act is adopted.

What Is in the Guidance?

The guidance is divided into four main parts:

  • Introductory Guides (01–02): Overview of the AI Act and key compliance principles.
  • Technical Guides (03–15): Practical recommendations relating to:
    • Conformity assessments
    • Risk management systems
    • Technical documentation
    • Record-keeping and transparency
    • Human oversight requirements
  • Toolkit of Checklists and Templates (16 and zip file): Guide 16 explains how to use compliance checklists and is complemented by a free, downloadable toolkit with ready-to-use templates and examples to aid implementation.

Why Does It Matter?

The guidance offers a practical roadmap for compliance with the AI Act and reflects Spain’s collaborative approach centered on its national AI sandbox, which brings together regulators, industry, and technical experts. Several EU countries are taking similar steps to support organizations seeking to comply with the AI Act. For instance:

  • Germany has issued guidance on high-risk AI classifications and safety standards.
  • The Netherlands published an AI Act Guide outlining obligations and risk categories with practical compliance steps.
  • France’s CNIL has issued recommendations focused on GDPR compliance, including data annotation, development security, and model governance—complete with checklists to help companies navigate personal data use in AI systems.

These efforts, similar to Spain’s, aim to equip organizations with the necessary tools to comply with the AI Act.

Ongoing regulatory developments on AI are closely monitored by experts who regularly advise leading technology companies on complex regulatory and compliance issues in the EU and other major markets. Organizations with questions regarding AI regulation or other technology regulatory matters are encouraged to seek professional assistance.

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