Announcement

Last update: 11/06/2025

RESOLUTION OF APPOINTMENT OF MEMBERS OF THE GROUP OF EXPERT ADVISERS

With date 10/06/2025 has been published in the electronic headquarters the Resolution appointing the members of the group of expert advisers referred to in RD 817/2023 of 8 November. You can consult the document at the following link: Resolution of Appointment of Members of the Group of Expert Advisers [PDF] [252 KB]

RESOLUTION

With date 30/04/2025 has been published in the electronic headquarters of the Ministry the resolution of the call for access to the controlled testing environment for a reliable artificial intelligence. You can consult the document at the following link: Proposed Provisional Resolution Refusal AEESD-1-2016 v1

MOTION FOR A RESOLUTION

Finalized the evaluation of the applications, dated 03/04/2025 has been published in the electronic headquarters of the Ministry the proposed resolution of the call for proposals. You can consult the document at the following link: Proposal for the Provisional Resolution [PDF] [281 KB]

THE DEADLINE FOR SUBMITTING APPLICATIONS IS EXTENDED UNTIL 30 JANUARY.

A technical inconvenience has been identified in the process of migration of the units to the Ministry for Digital Transformation and the Public Service, which previously depended on the Ministry of Economy. This inconvenience has generated the temporary interruption in the presentation of applications, from the 14th to the 17th of January. Once the problem has been solved, we have proceeded to verify that the system operates with total normality.

Due to this situation, the deadline for submitting applications is extended until January 30, by a resolution of the Secretary of State for Digitalization and Artificial Intelligence.

Send your candidacy here

INTRODUCTION

First call for the AI Sandbox

In order to promote the development and use of responsible AI, foster innovation and facilitate the implementation of the requirements for high-risk systems for companies, especially SMEs and startups, on November 8, 2023, the BOE published the Royal Decree 817/2023 By which a controlled testing environment in artificial intelligence is created.

In this context, the first call for the AI Sandbox for the purpose of carrying out a test of the requirements laid down for high-risk systems in the European Artificial Intelligence Regulation (Chapter III, Section 2).

This initiative seeks to minimize compliance costs, especially for SMEs and startups, by creating an environment that favors cooperation between the fields of innovation and regulation. It results in a report that contains good practices and conclusions gathered during the experience, as well as technical guidelines for implementation and monitoring based on evidence and experimentation that will be made available to the general public at the end of the same.

The objectives are:

  • Contribute Clarity on the requirements established in the regulation and validate the applicability of the technical implementation guides that will be made available to the entire population.
  • Transfer know-how on law enforcement for entities developing AI solutions.
  • Encourage the development of innovative and reliable AI systems.
  • Increasing the capacities and the knowledge in the field of supervision of Artificial Intelligence, which will then be reusable by the Spanish Agency for Supervision of Artificial Intelligence (AESIA).
  • Assess the impact of the Regulation and its obligations in a controlled environment, and provide practical experience and learning to support the development of standards, guidance and tools at national and European level.
  • Influence the development of the acts of execution of the Intelligence Regulation and the European standardisation processes on the regulation.
  • Making Spain a benchmark for AI development responsible in the EU and the world, supporting the competitiveness of our productive fabric and encouraging the creation of responsible AI solutions for social and economic challenges.

Presenting itself to consumers, companies, and Public Administrations as a Innovative, responsible and proactive organisation in the development of ethical Artificial Intelligence.

Better understanding of the European AI Regulation And how it can specifically affect your organization.

Participate in the Responsible development of AI products and services that can prove their value to the economy and society.

To have a high-level consultancy, information and advice with the follow-up of SEDIAas well as the AESIA and other responsible regulatory agencies that will assist in understanding and complying with the Artificial Intelligence Regulation. Also provide information on the experience itself, which will serve the institutions for their normative learning and the understanding of the weaknesses, threats, strengths and opportunities presented by this

Contribute to making Spain an innovative, competitive and pioneering economy in the development and deployment of AI responsible in the context of the EU.

Participation in the Sandbox IA does not imply that the entity has passed the conformity assessment of its high-risk Artificial Intelligence system, according to European regulations or other applicable regulations.

THE DEADLINE FOR SUBMITTING APPLICATIONS IS EXTENDED UNTIL 30 JANUARY.

A technical inconvenience has been identified in the process of migration of the units to the Ministry for Digital Transformation and the Public Service, which previously depended on the Ministry of Economy. This inconvenience has generated the temporary interruption in the presentation of applications, from the 14th to the 17th of January. Once the problem has been solved, we have proceeded to verify that the system operates with total normality.

Due to this situation, the deadline for submitting applications is extended until January 30, by resolution of the Secretary of State for Digitalization and Artificial Intelligence

Send your candidacy here

INTRODUCTION

They can access the text of the call for proposals In the following link. Applications with high-risk AI systems can be submitted from the December 23, 2024 to January 23, 2025 (EXTENDED)

The participants will be selected through one public announcement. They will be selected up to 12 high-risk artificial intelligence systems.

The artificial intelligence systems included in Annex I of the Call for Proposals (corresponding to Annex III of the AI Act) and the systems regulated by one of the following harmonized standards of the European Union will be eligible:

  1. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending Directive 95/16/EC (recast).
  2. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
  3. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

The systems presented they must already be placed on the market or put into service, or show a reasonable degree of advance, corresponding to a TRL greater than 6, which allows it to be placed on the market or put into service as soon as possible at the beginning of the post-marketing monitoring plan, with the aim of assessing the risks that the development and implementation of AI projects may entail in the future.

This call is directed to assist in particular SMEs and start-ups in fulfilling the obligations of the Artificial Intelligence Regulation for which at least one SME or startup must participate in the applicant AI systems. This will allow us to analyze the best way to implement the obligations of the regulation for this type of entities that normally have fewer resources.

The participating entities will have at their disposal a professional consultancy servicel offered by the public sector, as well as independent experts who will advise them during the process of adaptation of high-risk artificial intelligence systems.

As a result they will be obtained Technical implementation guides based on evidence and experimentation, the monitoring guide, good practices and recommendations and that once the Sandbox of IA is finished they will be published for dissemination and knowledge of the entities. Turning Spain into a leader in the development of responsible AI in the EU and in the world, supporting the competitiveness of our productive fabric and promoting the creation of AI solutions for social and economic challenges.

During this process the aim is to validate both the obligations of the providers of high-risk AI systems and that of the users (called responsible for deployment in the Regulation).

Starting with a Training Phase to ensure a better understanding of obligations, the provider, in coordination with its collaborators and users (if any), will develop An adaptation plan for your artificial intelligence system. This plan will be coordinated with SEDIA and will include the necessary actions and resources that the supplier will carry out to adapt to the Regulation.

During the Sandbox IA, the supplier must implement the adaptations established in the plan in his own environment, with an estimated duration of 6 months. This stage will conclude with one Self-assessment and declaration of compliance with the obligations. However, these will not have legal effects outside the scope of the controlled testing environment.

Subsequently, the supplier must present the post-marketing monitoring plan, with the aim of identifying possible risks.

The total approximate duration will be 12 months.