Chapter VI
Measures in Support of Innovation
AI regulatory sandboxes, real-world testing, derogations and dedicated supports for SMEs and start-ups.
- Art 57
AI Regulatory Sandboxes
Each Member State must establish at least one AI regulatory sandbox at national level by 2 August 2026, providing a controlled environment for the development, training, validation and testing of innovative AI systems before placing on the market, with regulatory guidance and supervision.
Cross-cuttingEffective 2026-08-02 - Art 58
Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes
Sets out the modalities of national sandboxes — admission criteria, supervision, reporting, exit strategies — and is supplemented by Commission implementing acts ensuring uniform conditions across Member States.
Cross-cuttingEffective 2026-08-02 - Art 59
Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
Permits — under strict conditions and only within an AI regulatory sandbox — the lawful further processing of personal data, originally collected for other purposes, for the development of AI systems in the public interest (e.g. health, environment, public safety).
Cross-cuttingEffective 2026-08-02 - Art 60
Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
Allows providers (and prospective providers) to test high-risk AI systems in real-world conditions outside sandboxes, subject to a real-world testing plan submitted to the market surveillance authority and registration in the EU database. Time-limited; with informed consent of test subjects.
High riskEffective 2026-08-02 - Art 61
Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes
Subjects of real-world testing must give freely-given, specific, unambiguous and informed consent before participating, with the right to withdraw at any time without detriment.
High riskEffective 2026-08-02 - Art 62
Measures for Providers and Deployers, in Particular SMEs, Including Start-Ups
Mandates priority access to AI sandboxes, awareness-raising, dedicated communication channels, and a fee structure for conformity assessment that takes the size of the SME into account.
Cross-cuttingEffective 2026-08-02 - Art 63
Derogations for Specific Operators
Micro-enterprises may comply with elements of the Article 17 quality management system in a simplified manner, provided they do not sub-contract or have partner enterprises.
High riskEffective 2026-08-02