We are excited to announce our participation in the EU-funded BRIDGE Project - a major European initiative to support innovative health technologies.
The EU-funded BRIDGE project (Breakthrough Regulatory Innovation and Development through sandbox Environments) officially begins its mission to deliver a framework for regulatory sandboxes for emerging health technologies in Europe. The project, which is a flagship of the Innovative Health Initiative (IHI), recognises that cutting-edge health innovations often do not fit neatly within existing regulatory frameworks, delaying their development and patient access. Regulatory sandbox mechanisms offer a way forward through experimentation.
Regulatory sandbox mechanisms offer a way to address this challenge by allowing innovators and regulators to collaborate early, test new approaches, and identify regulatory needs before a product or service reaches the market.
Cutting-edge health innovations often do not fit neatly within existing regulatory frameworks, delaying their development and patient access. Regulatory sandbox mechanisms offer a way forward through experimentation.
The implementation of regulatory sandboxes in healthcare is still in its early stages. In Europe, it remains only a concept in the biomedical and biotherapeutics field. Translating a concept into an effective tool is the challenge BRIDGE aims to address.
BRIDGE will deliver comprehensive policy recommendations to embed sandbox approaches sustainably into the European regulatory ecosystem. These will be supported by:
A proactive horizon-scanning approach to identify emerging technologies and methodologies that challenge current frameworks from fields of medicine, data, AI, in vitro diagnostics, medical devices, regenerative medicine, substances of human origin, gene editing, Internet of Medical Things, innovative clinical trials, new manufacturing approaches to name a few.
Regulatory readiness and eligibility criteria for determining when sandboxing is appropriate
The MOSAIC architecture, An operational blueprint for designing and running regulatory sandboxes. It will function as a configurable set of modules (‘bricks’) than can be adapted to different types of health innovations.
Case studies and simulations that test and refine the sandbox architecture in realistic scenarios.
Together, these outputs will support a more anticipatory, agile and adaptive regulatory environment for medical innovation across Europe.
