Challenge

European healthcare innovation is advancing faster than the regulatory frameworks designed to govern it. Many emerging technologies challenge existing rules, not because they are unsafe, but because current regulatory pathways lack the flexibility to assess them effectively. Althrough regulatory sandboxes offer a way to experiment with new regulatory approaches, their application in healthcare remains inconsistent across Europe. Differences in scope, maturity and operational design have limited their broader uptake and reduced their potential to support innovation in a coordinated and predictable manner.

Solutions

BRIDGE responds to this fragmentation by estabilishing a shared foundation for the design and use regulatory sandboxes in healthcare. Rather than promoting a one-size-fits-all model, the project develops a modular and adaptable sandbox approach that can be tailored to different regulatory needs while remaining alligned with European frameworks. To support this, BRIDGE systematically examines regulatory sandboxes already in operation across multiple sectors, identifying reusable components and design elements that can strengthen healthcare regulation.

Results

One of the central outputs of the project is the Modular Operational Sandbox for Healthcare Innovation and Compliance (MOSAIC). MOSAIC provides a structured architectural model built from interoperable modules, each supported by clear functional specifications and defined information flows. By linking these modules to real-world case studies, the model demonstrates how different regulatory challenges can be addressed through tailored sandbox configurations. IN addition, the project delivers operational tools such as checklists and evidence frameworks that support regulators and innovators in implementing sandboxes in a consistent and transparent manner. By strengthening the practical foundations of healthcare regulatory sandboxes, BRIDGE contributes to a more forward-looking and resilient regulatory environment in Europe. The project enables regulators to respond more effectively to innovation without compromising safety, quality or public trust.