The presentation in December 2025 of a new EU Health Package, including the proposed European Biotech Act and revisions to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) embed a number of provisions related to regulatory sandboxes. The proposed EU Biotech Act embeds targeted regulatory sandboxes as a core policy tool across clinical trials and other biotech-relevant regulatory frameworks, as stand-alone sandboxes in addition to sandboxes established under other frameworks. The proposed Act also establishes a foresight panel for emerging health innovations. This panel will conduct horizon scanning of emerging science and technology and facilitate exchanges among the different authorities responsible for the set-up and operation of regulatory sandboxes.
The expansion of sandboxing beyond pharmaceuticals and AI reflects the increasingly complex and interdisciplinary nature of healthcare innovation. Regulatory sandboxes are framed as time-limited, controlled environments that enable methodological and regulatory learning, allowing novel development approaches and trial designs to be explored while maintaining high standards of patient safety and scientific integrity.
For BRIDGE, the IHI-funded flagship project developing a comprehensive framework for healthcare regulatory sandboxes, these developments strongly reinforce the project’s mission and relevance.
A learning opportunity for BRIDGE
Relevant measures under the proposed Biotech Act and MDR/IVDR simplification clearly align with BRIDGE’s objectives and work programme. BRIDGE is designed as a learning-oriented initiative, connecting horizon scanning, sandbox design as well as regulatory and methodological learning across the healthcare innovation lifecycle.
In this evolving policy context, BRIDGE is well positioned to add value by:
- Linking foresight to action, through horizon scanning that identifies biotech and healthcare innovations where regulatory sandboxes can most effectively accelerate innovation;
- Operationalising sandboxes, by developing concrete frameworks, operating principles, governance models, and methodological guidance that support legally robust and scientifically sound experimentation while safeguarding patients;
- Supporting regulatory learning, by simulating end-to-end sandbox case studies and analysing how regulators, innovators and health systems learn through sandbox participation and translate experimentation into real-world, scalable healthcare solutions.
Looking ahead: Translating policy ambition into practice
While the proposed legislative changes will now progress through the EU co-decision-making process and may evolve before adoption, the direction of travel is clear: Regulatory sandboxes are part of a broader shift toward strategies for anticipatory governance and innovation-friendly oversight.
For BRIDGE, this moment represents both an opportunity and a responsibility: to help translate policy ambition into workable, scalable sandbox models that deliver meaningful regulatory learning and real-world, scalable solutions, providing tangible benefits for patients, innovators, health systems and the wider society across Europe.