AI reg­u­la­to­ry sand­box­es

• What is an AI regulatory sandbox?
• What are the aims of AI regulatory sandboxes?
• Pilot project for AI regulatory sandbox simulation
• Participation in the EUSAiR pilot project for AI regulatory sandboxes

What is an AI regulatory sandbox?

Regulatory sandboxes are a modern regulatory tool that fosters innovation by facilitating the testing of innovative services, products or technologies in as far as possible real world conditions and under the oversight of the competent authorities.

AI regulatory sandboxes established under the AI Act provide for a controlled environment to foster innovation. They facilitate the development, training, testing and validation of innovative AI systems for a limited period of time – even before their being placed on the market or put into service – on the basis of a sandbox plan agreed with the competent authority. New and complex legal questions from businesses are examined under the guidance of the competent authorities with a view to ensuring that the businesses’ AI systems comply with the AI Act and other applicable law before being placed on the market or put into service. The activities carried out in the sandbox and the related results and learning outcomes are detailed in an exit report. This aims to facilitate and accelerate access to the market, in particular for SMEs and start-ups.

AI regulatory sandboxes may be established in physical, digital or hybrid form and may accommodate physical as well as digital products. Testing in real world conditions may also be carried out and supervised in the framework of AI regulatory sandboxes.

The European Commission will adopt implementing acts specifying the detailed arrangements for the establishment, development, implementation, operation and supervision of AI regulatory sandboxes, probably before the end of the year. The European Artificial Intelligence Board’s sub-group on regulatory sandboxes is supporting the Commission in developing the implementing acts, which will be submitted to the AI comitology committee before they are adopted.

What are the aims of AI regulatory sandboxes?

The establishment and the operation of AI regulatory sandboxes aim to contribute to the following objectives:

• Fostering innovation: A controlled environment facilitates the development, training, testing and validation of innovative AI systems. The learning outcomes from regulatory sandboxes are made available to all AI innovators.
• Enhancing legal certainty: Oversight by the authorities ensures regulatory compliance with the AI Act and other applicable law and reduces legal uncertainty.
• Facilitating regulatory learning: The experience from AI regulatory sandboxes facilitates regulatory learning for authorities and undertakings, also with a view to future adaptations of the legal framework.
• Accelerating access to the market: Removing barriers improves access to AI systems on the Union market, in particular for SMEs and start-ups.
• Promoting exchange: Cooperation between all the authorities involved in the AI regulatory sandbox supports the sharing of best practices.

Pilot project for AI regulatory sandbox simulation

The Bundesnetzagentur, the Hessian Ministry for Digitalisation and Innovation and the Federal Commissioner for Data Protection and Freedom of Information launched a joint pilot project for the simulation of an AI regulatory sandbox in May 2025. The aim of the project is to simulate key requirements, processes and challenges of AI regulatory sandboxes within the meaning of the AI Act in realistic conditions and expand knowledge and findings on AI regulatory sandboxes. The results from the pilot project will provide guidance for the future establishment and operation of real AI regulatory sandboxes and will be available soon.

The final report was published in March 2026. Further information can be found in the press release on the project completion net borrowing 17.03.2026. In addition to the overarching findings on the conception and successful operation of AI regulatory sandboxes, the practical experiences of accompanying two use cases from the medical AI field resulted in a results document that clearly presents the high-risk AI requirements for AI-based medical devices.

Participation in the EUSAiR pilot project for AI regulatory sandboxes

The EUSAiR pilots offer companies the opportunity to test their innovative AI systems in real or simulated environments for regulatory compliance under the AI Act. With the help of expert advice, regulatory challenges are identified, solutions are tested and practical feedback is provided to help shape the future implementation of AI regulatory sandboxes in the EU.

The pilots will take place between October 2025 and June 2026. Up to 90 use cases can be considered. Companies from all sectors and of all sizes are eligible to participate. Applications are accepted on an ongoing basis.

eUSAiR is a two-year project funded by the EU's Digital Europe programme. It supports the establishment of AI regulatory sandboxes in the EU to promote AI innovation, improve legal certainty and facilitate compliance with the AI Act.