Healthcare is under increasing pressure due to an aging population and limited resources. Innovative healthcare technologies hold the promise of addressing many current challenges. Emerging therapies often combine multiple modalities - such as gene and cell therapies, tissue-engineered products, and AI-driven medical devices - into integrated advanced therapies with the potential to significantly improve patient outcomes and quality of life.
The EU-funded BRIDGE project develops a framework that enables a rapid set-up of sandbox instances aligned with the specific requirements of those technologies. Healthcare innovations are governed by multiple regulatory frameworks. Medicinal products fall under the proposed EU General Pharmaceutical Legislation, which will, over the coming years, replace and consolidate several existing regulations. Medical devices are regulated under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), and AI-enabled devices must also comply with the EU Artificial Intelligence Act (AI Act). Additional EU regulatory frameworks cover substances of human origin, while new regulations are emerging for biotechnology products.
A major challenge is that many healthcare innovations cannot be developed in full compliance with existing regulatory frameworks, or compliance would significantly delay and complicate the development.
Regulatory sandboxes have been proposed as a way to address this challenge. A regulatory sandbox is a time-limited arrangement in which innovators can develop and test a product with regulatory adaptations under the supervision of the relevant competent authority. Sandboxes facilitate close interaction between innovators, authorities, and other stakeholders, helping to ensure regulatory compliance while supporting successful product development.
Regulatory sandbox framework by BRIDGE project
BRIDGE is a three-year flagship project of the Innovative Health Initiative, delivered by 28 organisations from 12 countries, partially funded by the EU. These partners represent pharmaceutical industry, regulators, health technology assessment (HTA) bodies, research organisations, as well as EU intergovernmental associations, member states and regions. The project is carried out in the time frame of 1 November 2025 – 31 October 2028.
The BRIDGE project develops a framework, which facilitates identification and assessment of healthcare technologies suitable for regulatory sandboxes, and enables a rapid set-up of sandbox instancies aligned with the specific requirements of those technologies. Identification of suitable technologies is based on proactive horizon scanning methodology, while the assessment is supported be unified criteria and acceptance process. For setting up regulatory sandboxes, BRIDGE develops a novel approach, called MOSAIC (Modular Operational Sandbox for Healthcare Innovation and Compliance). MOSAIC enables a regulatory sandbox to be constructed by using generic and customized “bricks”, which include various types of resources (e.g. templates, tools, processes and personnel) for implementing a regulatory sandbox for a specific purpose.
The BRIDGE project will test the MOSAIC approach by “table-top” simulations of the end-to-end sandbox process through case studies representing different types of healthcare innovation development. The simulations are collaborative walk-through sessions in which the sandbox process and related documentation are reviewed with participation from all relevant stakeholders. The simulations inform the iterative development of the MOSAIC model. The final simulation results are consolidated and further developed into recommendations for dissemination.
VTT’s role in the BRIDGE project
VTT is a major contributor in the BRIDGE project with leading position in end-to-end regulatory sandbox simulations, MOSAIC model catalogue development and the analysis of existing regulatory sandbox mechanisms. The participation of VTT in BRIDGE is well aligned with its mission of advancing the development and deployment of innovative technologies in the society. The project builds on VTT’s earlier contributions to the TEHDAS Joint Action on European Health Data Space (EHDS) infrastructures and to the planning of a national regulatory sandbox for AI.
The BRIDGE project strengthens VTT’s position to develop innovative and compliant products for companies and healthcare actors by taking regulatory challenges into account already during planning phase.
VTT will further exploit learnings from the BRIDGE project in contract research for companies and in collaborative projects with industry and academia aiming at successful commercialisation aligned with complex regulatory environment of healthcare technology. Additionally, experience from the BRIDGE improves VTT’s capability to support SMEs and startups which do not have large regulative expertise of their own.
