Excited to kick off our 3-day BRIDGE General Assembly & Consortium Meeting in Dijon 🇫🇷! Over the next days, we’ll be working on: 🔹 Building a shared understanding of regulatory sandboxes and their role across sectors 🔹 Aligning on key project outputs and expected impact 🔹 Exploring real-world technology examples and regulatory challenges 🔹 Designing and testing end-to-end sandbox simulations 🔹 Addressing legal, ethical, and eligibility aspects of sandbox implementation 🔹 Advancing our case studies and knowledge hub to support uptake and dissemination This work is particularly timely. Regulatory sandboxes are gaining strong momentum across the EU as a key instrument to support innovation while ensuring safety, compliance, and trust. Looking forward to three days of intense discussions, collaboration, and co-creation with an outstanding consortium! If you want to know more or do not want to miss any opportunities for collaboration with BRIDGE, make sure to sign up here: https://lnkd.in/esPtKmDr #BRIDGEproject #HealthInnovation #RegulatorySandboxes #HealthPolicy #DigitalHealth #EUHealth #Healthcare #Innovation Innovative Health Initiative (IHI)
BRIDGE
Research Services
This project is supported by the Innovative Health Initiative Joint Undertaking under grant agreement No 101165912.
About us
BRIDGE (Breakthrough Regulatory Innovation and Development throuGh sandbox Environments) is an EU-funded flagship project of the Innovative Health Initiative (IHI). It brings together 28 organisations from 12 countries, representing regulators, health technology assessment (HTA) bodies, research organisations, intergovernmental associations and multi-stakeholder associations at EU, member state (MS) and regional levels. BRIDGE is building a flexible, modular and evidence-based framework for regulatory sandboxes in health. Sandboxes are controlled environments where innovators and regulators can safely test new technologies and explore regulatory adaptations needed to bring them to patients faster. BRIDGE will deliver: • A proactive horizon-scanning approach to identify technologies that challenge current frameworks • Regulatory readiness and eligibility criteria for determining when sandboxing is appropriate • The MOSAIC architecture (Modular Operational Sandbox for Healthcare Innovation and Compliance), a configurable suite of “bricks” and modules for running tailored regulatory sandboxes • Case studies covering areas such as AI, digital health, advanced therapies, emergency preparedness and innovative non-clinical testing methods • Comprehensive policy recommendations to embed sandbox approaches sustainably into the European regulatory ecosystem
- Website
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https://bridge-ihi.eu/
External link for BRIDGE
- Industry
- Research Services
- Company size
- 11-50 employees
- Founded
- 2025
Updates
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Great to have brought the BRIDGE WP1 task leaders together in Cologne. IHI BRIDGE project (https://bridge-ihi.eu) develops frameworks for regulatory sandboxes for Europe. A productive workshop with valuable discussions on progress, next steps and synergies across tasks. Thanks to Stephane Callevaert, Zoe Garay, Bettina Döpner, Mika Naumanen, Christophe Maes, Martina Schneider, Pedro Franco, Lysbeth Bakker, Hans-Peter Dauben, Maximilian Otte and all contributing partners attending the meeting." #IHIBridge #BRIDGEProject #WP1 #HealthInnovation #RegulatorySandboxes #Cologne
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Great to see the discussion on “An Agile EU Regulatory System that Fosters Innovation” at #DIAEurope2026. From the #BRIDGE consortium perspective, this was particularly valuable to have our coordinator Gokhan Ertaylan present BRIDGE and highlight how regulatory sandboxes poised to serve as a key mechanism to connect innovation, agile learning with regulatory frameworks. Sandboxes are expected to provide evolvability functionality for regulatory pathways complementing agile scientific advice and initiatives like #PRIME—by enabling iterative learning, earlier alignment, and robust evidence generation. We strongly believe that such approaches are essential for strengthening Europe’s position as both a science-driven and innovation-friendly ecosystem. Many thanks to the organisers, especially Michael Berntgen and Laura Oliveira, for facilitating such an engaging and forward-looking session. We would be very interested to connect with stakeholders working in this space—if you are exploring or implementing regulatory sandbox approaches, feel free to get in touch. #EMA #RegulatoryScience #Innovation #BRIDGE #DIAEurope
“An Agile EU Regulatory System that Fosters Innovation” – this was the title of an exciting session at #DIAEurope today. In a global environment where science is moving faster than ever, agility is a key driver of competitiveness for Europe. Early and iterative scientific dialogue improves evidence quality and helps prevent misalignment. We discussed three tools to reimagine #EMA ’s development support offering: the provision of agile scientific #advice, recent advances of the #PRIME scheme, as well as the evolution of regulatory #sandboxes. My thanks to the distinguished panellists who shared their insights and experience with the participants, and to my co-chair Laura Oliveira for a fantastic collaboration in setting up and guiding through this debate. We trust this session has provided useful insights and, above all, has reinforced the importance of continued dialogue as we shape the future of regulatory agility in Europe.
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Thank you Innovative Health Initiative (IHI) for highlighting our Initiative for an interesting weekend reading. Check our website, we won’t disappoint.
📗 Looking for some #WeekendReading? Head over to the EFPIA - European Federation of Pharmaceutical Industries and Associations' blog post about the value of IHI. Read about these new projects in the article: 🫀 Cities@Heart — IHI is looking at the potential role of Europe’s cities in combatting heart disease ⛱️ BRIDGE is developing recommendations for designing and implementing ‘regulatory sandboxes’ – flexible spaces where innovators and regulators can explore the best way to regulate new technologies. 🤝 IHI-UNIFIED is integrating different ways of collecting patient input to put patients at the heart of clinical decision-making 🦴 IHI PROBE is using big data to advance the care of people living with knee osteoarthritis. 👩💻 LIGAND AI is harnessing computer models to predict whether certain molecules are likely to bind to proteins and change how that protein behaves. 🩺 GUIDE-AI is building ‘guideline navigators’ powered by large language models (LLMs) that allow clinicians to quickly identify the right treatment for each patient 🦠 END2AMR is seeking to reinvigorate the development of new treatments for drug-resistant infections. Read it here: 👉 https://lnkd.in/dUS3jfqU #IHITransformingHealth #HorizonEU #PublicPrivatePartnership #HealthResearch
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If you are a postdoctoral researcher interested in regulatory science, this might be for you! BRIDGE partner Novo Nordisk is looking for you.
If you’re passionate about shaping the future of regulatory science, this is your chance! Novo Nordisk is looking for a talented Postdoctoral Researcher in REGULATORY SCIENCE to join the BRIDGE project - a 3-year IHI flagship initiative dedicated to regulatory innovation. You will be part of my Public–Private Partnerships team, work very closely with our Global Regulatory Policy colleagues on a daily basis, and join a network of postdocs across multiple project. #BRIDGEproject
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Learn more about what BRIDGE is doing to advance the uptake of regulatory sandboxes in healthcare. Hear from its coordinators 👉 www.bridge-ihi.eu The BRIDGE project aims to create shared knowledge, practical tools, and a collaborative community. On the website, you can explore: 🌟 What BRIDGE aims to achieve in strengthening innovation pathways 🤝 Consortium partners and their roles across research, industry, and policy 📣 Opportunities to engage — including events, resources, and community activities The website will serve as the central hub for updates, insights, and ways to get involved. Sign up to not miss any announcements and opportunities for engagement: https://lnkd.in/esPtKmDr #BRIDGEproject #HealthInnovation #RegulatorySandboxes #HealthPolicy #BRIDGEwebsiteLaunch #DigitalHealth #EUHealth #Healthcare #Innovation
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🚀 A strong signal for regulatory innovation in European health policy Yesterday, the European Commission presented a new Health Package that sends a clear and welcome message: innovation and patient safety must advance together. From the perspective of BRIDGE, we particularly welcome two developments that strongly reinforce the EU’s commitment to adaptive, future-ready regulation: 🔬 The European Biotech Act proposes a structured EU-level horizon scanning framework (Articles 37–38) to systematically identify emerging biotechnologies, anticipate regulatory challenges early, and inform policy and regulatory responses. Crucially, this forward-looking mechanism is directly linked to regulatory sandboxes (Articles 39–40), which are positioned as practical instruments to test novel biotechnologies, regulatory approaches, and evidence-generation pathways in a controlled and collaborative setting – before market entry. 🩺 The proposed revision of the Medical Devices and IVD framework complements this approach by formally enabling regulatory sandboxes for emerging technologies, allowing regulators, innovators, and other stakeholders to work together in real-world conditions, while maintaining a high level of patient safety and public health protection. Together, these initiatives reflect a clear policy shift: 👉 anticipatory governance, early dialogue, and structured experimentation are becoming core components of EU health regulation. This is precisely where BRIDGE contributes. As an IHI-funded project, BRIDGE is developing concrete frameworks, methodologies, and evidence packages to help design and operationalise regulatory sandboxes in healthcare – connecting horizon scanning, regulatory learning, and implementation on the ground. We applaud the EU for embedding sandboxes and horizon scanning into its health legislation and look forward to supporting their effective and coherent deployment across Europe. #BRIDGEproject #HealthInnovation #RegulatorySandboxes #HealthPolicy #DigitalHealth #EUHealth #Healthcare #Innovation
🎉We are ending the year on a high note! The Health Package proposed today is a win-win approach to better healthcare. It will improve the health of EU citizens, strengthen the resilience of our health systems and boost competitiveness in the health sector. The Package is made up of three major initiatives: 🧬 The Biotech Act to turbo-charge the EU’s biotechnology sector and help get ground-breaking innovative medicines to EU patients, faster. 🔬 Revised rules for medical devices will make life simpler for EU companies and promote innovation, while protecting patient safety. ♥️ The EU Safe Hearts Plan will tackle EU’s number one killer – cardiovascular diseases - with targeted measures to improve prevention, diagnosis, treatment and care. Together, these initiatives will be a game changer for patients and companies across the EU. They will help build a more modern, dynamic, and resilient health ecosystem — while ensuring Europe has the most innovative and effective treatments and therapies possible. 👀Keep a close eye on our LinkedIn as we deep-dive into each initiative later this week. Find out more about the health package here: 🔗https://lnkd.in/gXDdiDK9 Learn more about the Biotech Act here: 🔗https://lnkd.in/g-3CuvVR Learn more about the Revised rules for medical devices here: 🔗https://lnkd.in/gJen9ca3 Learn more about the #EUSafeHeartsPlan here: 🔗https://lnkd.in/gEmytej4 #HealthUnion European Medicines Agency European Centre for Disease Prevention and Control (ECDC)
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Have you visited the BRIDGE project website yet? 👉 www.bridge-ihi.eu The BRIDGE project aims to accelerate the uptake of regulatory sandboxes in healthcare across Europe by creating shared knowledge, practical tools, and a collaborative community. On the website, you can now explore: 🌟 What BRIDGE aims to achieve in strengthening innovation pathways 🤝 Consortium partners and their roles across research, industry, and policy 📣 Opportunities to engage — including events, resources, and community activities The website will serve as the central hub for updates, insights, and ways to get involved. #BRIDGEproject #HealthInnovation #RegulatorySandboxes #HealthPolicy #BRIDGEwebsiteLaunch #DigitalHealth #EUHealth #Healthcare #Innovation
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We are excited to announce the launch of the BRIDGE Project website! 👉 www.bridge-ihi.eu The BRIDGE project aims to accelerate the uptake of regulatory sandboxes in healthcare across Europe by creating shared knowledge, practical tools, and a collaborative community. On the website, you can now explore: 🌟 What BRIDGE aims to achieve in strengthening innovation pathways 🤝 Consortium partners and their roles across research, industry, and policy 📣 Opportunities to engage - including events, resources, and community activities The website will serve as the central hub for updates, insights, and ways to get involved. We look forward to growing the BRIDGE community with you! #BRIDGEproject #HealthInnovation #RegulatorySandboxes #HealthPolicy #BRIDGEwebsiteLaunch #DigitalHealth #EUHealth #Healthcare #Innovation Innovative Health Initiative (IHI)
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🚨 Press Release: BRIDGE Project Launches to Advance Regulatory Sandboxes for Healthcare Innovation BRIDGE – an Innovative Health Initiative (IHI) flagship project – sets out to develop a European framework for regulatory sandboxes that can help emerging health technologies reach patients faster and more safely. The press release highlights BRIDGE’s mission to: 🔹 build the foundations of a more agile, future-oriented regulatory system 🔹 develop a flexible architecture for designing and running regulatory sandboxes 🔹 establish readiness criteria and horizon-scanning approaches 🔹 test and refine sandbox concepts through case studies and simulations With 28 organisations across 12 countries, BRIDGE brings together regulators, HTA bodies, industry, research organisations, and EU-level associations to shape a more adaptive regulatory ecosystem. 📄 Read the full press release here: https://lnkd.in/emRkVZHm #BRIDGEproject #HealthInnovation #RegulatorySandboxes #HealthPolicy #BRIDGEpressRelease1 #DigitalHealth #EUHealth #Healthcare #Innovation Innovative Health Initiative (IHI)
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