What is a regulatory sandbox for innovative products?

Dutch term: Regulatory sandbox / innovatiegerichte regelgeving | Legal basis: Various EU regulations

A regulatory sandbox is a controlled environment in which innovative products, services or business models can be tested under regulatory supervision without full compliance with all applicable rules. The EU AI Act explicitly provides for AI regulatory sandboxes, and similar concepts are emerging in other product regulation frameworks for products that do not fit neatly into existing conformity assessment categories.

In the Netherlands, the NVWA and other authorities have shown willingness to engage in structured dialogue with manufacturers of innovative products that challenge existing regulatory boundaries. While there is no general Dutch regulatory sandbox statute, individual regulators can exercise discretion in enforcement and can facilitate test environments within the existing legal framework.

Why it matters for international businesses

For manufacturers of innovative products (AI systems, novel medical devices, novel energy products) that do not fit standard conformity assessment procedures, engaging with the regulator early can open pathways to market access that pure compliance-by-the-book would not provide.