BRIDGE Project Launches to Advance Regulatory Sandboxes for Healthcare Innovation

Brussels, 2 December 2025 – 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, determine the most effective regulatory pathways for cutting-edge health technologies – supporting their development and smooth entry into the market.

A major European initiative to support innovative health technologies

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 equips Europe with a comprehensive framework to develop and assess emerging health technologies safely and collaborative effort, we efficiently. Through can align regulatory processes with innovation and deliver promising solutions to patients faster.

Gökhan Ertaylan, BRIDGE coordinator, VITO Flemish Institute for Technological Research

Building the foundations for a flexible and future-oriented regulatory system

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.

For industry, early regulatory alignment is essential. BRIDGE will help reduce uncertainty and support faster, responsible development of breakthrough therapies and technologies.

Geert Preuveneers, BRIDGE industry co-lead, MSD Regulatory Affairs Europe

A strong public-private partnership to drive change

The BRIDGE consortium consists of 28 organisations from 12 countries, of which 13 are public partners and 15 industry partners. These organisations include regulators, health technology assessment (HTA) bodies, research organisations, intergovernmental associations and multi-stakeholder associations at EU, member state (MS) and regional levels.

This balanced public-private partnerships brings together diverse perspectives essential for developing solutions that work across the healthcare ecosystem.

This groundbreaking public-private partnership positions us uniquely to advance our ambitious shared mission. At our recent kick-off meeting, representatives from all partner organisations came together for two days of presentations, strategic planning, and collaborative working sessions. Their diverse perspectives and expertise enriched the discussions, laying a strong foundation for our collective efforts moving forward.

This pre-competitive regulatory science project is unique. BRIDGE is about increasing the readiness of Europe to make use of effective regulatory sandboxes for innovative healthcare methodologies development technologies and

Francois Hebraud, BRIDGE industry co-lead, ROCHE EU Regulatory Policy Lead

Over the next three years, BRIDGE will develop Europe’s first comprehensive regulatory sandbox framework for health. In this process, BRIDGE aims to engage in dialogue with various stakeholders. Interested individuals and organisations are encouraged to subscribe to the project in order to be kept up to date on relevant engagement opportunities.

The University Medical Center Groningen (UMCG) role in BRIDGE

The UMCG team contributes to BRIDGE through its expertise in clinical research, personalised medicine and regulatory science. Within the project, the organisation plays a key role in formulating regulatory sandbox readiness criteria and selecting case studies. By participating in BRIDGE, the UMCG aims to accelerate the translation of research into practice, enhance precision healthcare, and foster collaboration between clinical and technological domains for better health outcomes. The organisation also supports community building, MOSAIC development, and integration of regulatory sandbox mechanisms within the EU healthcare and regulatory environment to advance the project’s shared mission.

This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101165912. The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, EuropaBio, MedTech Europe, and Vaccines Europe.

A full list of the partners can be found here: https://bridge-ihi.eu/about/consortium

Funded by the European Union, the private members, and those contributing partners of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.