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Record STMT-W75917AAdvisory

Guide 1. Introduction to the AI Act

Guidelines State lawWestern Europe · ESadopted

This document is an introductory guide developed within the framework of the Spanish AI regulatory sandbox pilot to help organizations understand the European Regulation on Artificial Intelligence (AI Act). It outlines market surveillance governance, classification of AI risk levels, operator roles and definitions, and the main obligations associated with high-risk AI systems and transparency. Additionally, it provides guidance on conformity assessments and details implementation timelines for different system types.

Summary and content fields are drawn from the document text and are pending editorial review.

Who issued it

Ministerio para la Transformación Digital y de la Función PúblicaGovernment (executive) · ES
Lead issuer
Legal forceAdvisory
Under whose authorityState law
Judged fromfull text

Who it governs

CompaniesPublic sector bodiesAI developers and providersAI deployers and users

This guide is for companies, developers, deployers, and public sector bodies seeking to understand their obligations under the European AI Act.

Sectors
Cross-sector

What the document contains

What's covered

The document covers the scope and structure of the European AI Act, definitions of relevant operators, market surveillance governance, risk-based classifications, and detailed obligations for high-risk systems and transparency requirements. It also outlines conformity assessment procedures and implementation timelines.

What's missing

It does not provide binding legal rules or substitute for the official text of the European Regulation on Artificial Intelligence, serving instead as a non-binding introductory guide.

Key takeaways
  • The guide provides an introductory support to the European Regulation on Artificial Intelligence and its applicable obligations for various market operators.
  • AI systems are classified by risk levels, ranging from prohibited practices and high-risk applications to systems with specific transparency obligations and minimal risk.
  • High-risk AI systems are subject to strict requirements including risk management, data governance, technical documentation, record-keeping, transparency, human oversight, accuracy, robustness, and cybersecurity.
  • The document outlines specific roles in the value chain, such as providers, deployers, importers, distributors, and authorized representatives.
  • Public sector deployers of certain high-risk AI systems must carry out fundamental rights impact assessments (EIDF / FRIA).
Principles it states
Avoid bias and non-discriminationCybersecurity, robustness and accuracyQuality management system and risk management systemHuman-centric technological development
Outline
· 1. Preamble
  - 1.1 Objective of the document
· 2. Introduction
  - 2.1 Introduction to the European Regulation on Artificial Intelligence
  - 2.2 Market Surveillance Governance
  - 2.3 Risk levels of the European Regulation on Artificial Intelligence
  - 2.4 Operators under the European Regulation on Artificial Intelligence
  - 2.5 AI regulatory sandboxes
· 3. Main Obligations
  - 3.1 AI literacy obligations
  - 3.2 Transparency obligations
  - 3.3 Obligations of high-risk systems
  - 3.4 Obligation activation dates
· 4. ANNEX I. Conformity assessment of high-risk AI systems and Market Surveillance Authorities
Issued17 July 2026
Length6,971 words
FormatNot recorded
Scopenational

How it scores

Pending review

Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.

Accountability

4/5

Clear responsibility for AI outcomes

The European Regulation on Artificial Intelligence mentions all potential roles involved in the value chain of AI systems (operators). The goal is to establish the responsibilities that each of these roles must assume during the life cycle of AI systems.

2.4 Operators under the European Regulation on Artificial Intelligence

screening score · 2026-10-23

Fairness

4/5

Non-discrimination and equitable treatment

Avoid bias and non -discrimination. Prevent algorithms from having discrimination problems and look for ways to make the results obtained explainable.

2.1 Introduction to the European Regulation on Artificial Intelligence

screening score · 2026-10-23

Human Dignity

2/5

Respect for the inherent worth of persons

However, along with its advantages, there are also important ethical, social and legal challenges that require special attention.

2.1 Introduction to the European Regulation on Artificial Intelligence

screening score · 2026-10-23

Human Oversight

4/5

Humans remain in control of consequential decisions

People need to be able to keep an eye on the operation of high -risk AI systems. To this end, systems must provide the necessary tools and interfaces to exercise this supervision and interact with them in a secure manner.

Human Oversight (Article 14)

screening score · 2026-10-23

Privacy

3/5

Protection of personal data and private life

mitigation of risks to health, safety, and fundamental rights, and applies preventive and corrective controls throughout the system's lifecycle.

2.1 Introduction to the European Regulation on Artificial Intelligence

screening score · 2026-10-23

Transparency

4/5

Openness about how AI systems work and are used

Article 50 lays down transparency obligations, requiring providers and those responsible for deployment to provide clear and understandable information when people interact with an AI system

3.2 Transparency obligations

screening score · 2026-10-23

Enforcement

4/5

Consequences and compliance mechanisms with real force

Market Surveillance Authorities ( MSAs) play an operational role in controlling, inspecting and monitoring compliance. They are responsible for verifying that the AI systems placed on the market or in service meet the established requirements and may impose corrective or sanctioning measures in the event of non-compliance.

2.2 Market Surveillance Governance

screening score · 2026-10-23

Impact Assessment

4/5

Required assessment of an AI system's risks/impacts before or during use

before deploying certain AI systems, an additional obligation is established to carry out an impact assessment of the potential impact of using certain high-risk AI systems on fundamental rights.

2.4.3 Individuals of public sector operators

screening score · 2026-10-23

Topics

ai_act compliance high_risk_ai regulatory_sandbox transparency_obligations