BRIDGE: Breakthrough Regulatory Innovation and Development throuGh sandbox Environments

Status: Ongoing Health

In BRIDGE, we will develop a framework and practical recommendations for end-to-end regulatory sandbox implementation for emerging technologies, enabling regulators, healthcare innovators, and decision-makers to sustainably embed sandbox approaches within the European regulatory ecosystem.

Modern healthcare is advancing at a pace that often outstrips traditional regulatory systems, particularly in areas like AI-driven diagnostics, gene editing, and the Internet of Medical Things. Our research in Regulatory Science focuses on solving this ’pacing problem’ by creating anticipatory pathways for these complex technologies. Through BRIDGE, we are moving away from retrospective compliance and toward an agile model where regulators, health technology assessment (HTA) bodies, and innovators collaborate early in the development lifecycle. This proactive and adaptable approach reduces market uncertainty and ensures that the European regulatory ecosystem remains a global leader in medical R&D.

Navigating the Frontier of Health Innovation

BRIDGE is a three-year flagship project funded by the Innovative Health Initiative. The consortium consists of 28 partners (40 organizations) across 12 countries and is coordinated by VITO. These partners represent regulators, health technology assessment (HTA) bodies, research organisations, intergovernmental and multi-stakeholder associations at EU, Member State, and regional levels, as well as industry leaders.

The project aims to develop a harmonised framework for ‘regulatory sandboxes’: safe, flexible, real-world test environments where innovators and regulators can collaborate. Together, they explore how to regulate new technologies effectively ensuring end-user protection while removing unnecessary barriers that may hinder innovation. By fostering agile, evidence-based regulation, BRIDGE helps accelerate the safe and timely introduction of groundbreaking healthcare solutions, ultimately benefiting patients and health systems across Europe.

The MOSAIC Framework: A Scalable Blueprint

At the heart of our methodology is the development of the MOSAIC architecture: a modular, operational blueprint designed to make regulatory sandboxes configurable for any health innovation. This framework is supported by our advanced horizon-scanning capabilities, which identify emerging technologies before they hit regulatory bottlenecks. By conducting realistic simulations and testing eligibility criteria, we provide a structured, evidence-based pathway that allows for the safe experimentation of new manufacturing approaches and innovative clinical trials, providing a more anticipatory, agile and adaptive regulatory environment for medical innovation across Europe.

VITO's role in BRIDGE

As the project coordinator, VITO's Digital Bio Systems (DBS) experts bring their multidisciplinary expertise across data science, health innovation, and systems integration. VITO steers the project’s strategic direction, ensures coherence across all activities, and leads the development of the MOSAIC framework. Within BRIDGE we start from our learnings and expertise from other ongoing EU projects, such as REALM, RAIDO and TEF Health, and we expand these to create a roadmap for Healthcare innovation in Europe.

Through BRIDGE, VITO aims to help shape a connected and future-proof European healthcare innovation ecosystem that accelerates responsible, impactful digital health solutions.