Initiative overview
The initiative consists of a structured set of 16 guidelines developed within the Spanish AI regulatory sandbox pilot, involving participants, technical assistance providers, competent national authorities and an expert advisory group. It is intended to support organisations in applying the European Artificial Intelligence Act by providing practical guidance aligned with regulatory requirements, while remaining non-binding. The materials are designed to contribute to a broader process in which European Commission guidelines will ensure consistent application of the regulation across Member States.
The guidelines are organised into three main components: two introductory guides that explain key concepts, definitions, risk levels and examples; a series of technical guides covering specific requirements for AI systems; and a checklist manual that supports self-assessment. The technical guides address areas explicitly set out in the AI Act, including conformity assessment, quality management, risk management, human oversight, data and data governance, transparency, accuracy, robustness, cybersecurity, records, post-market monitoring, serious incident handling and technical documentation. A complementary set of checklists and examples is also provided.
The initiative outlines measures and procedures that providers and deployers can use to meet obligations, including monitoring systems, documentation practices, reporting processes and operational controls across the lifecycle of AI systems. The inclusion of a checklist manual and self-assessment elements indicates a focus on operationalising compliance in a structured and repeatable way.
The materials are subject to continuous evaluation and periodic updates in line with evolving standards and guidance from the European Commission.
