Strengthening regulatory science for patient-centred innovation through the HORIZON-HLTH-2026-01-IND-03 call topic
26th November 2025 at 11:44 am
From AI-powered diagnostics to virtual human twins and new approach methodologies (NAMs), Europe’s health innovation landscape is evolving faster than its regulatory frameworks. The HORIZON-HLTH-2026-01-IND-03 call aims to close that gap by funding projects that update and advance regulatory science; the evidence base that underpins the safety, performance and adoption of health technologies.
This Research and Innovation Action (RIA) is the only call topic under the Destination ‘Maintaining an innovative, sustainable, and competitive EU health industry’ for the 16 April 2026 deadline. Under it, four projects with a contribution of € 4 to € 6 million per project are expected to be funded. With the deadline still six months away, this is the right moment to start shaping a strong, multi-stakeholder proposal. In this blog, we explain what the European Commission (EC) expects and share practical tips to help you design a project that bridges innovation, regulation and patient trust.
Addressing the regulatory science
Health technologies are increasingly complex, combining biological, digital and data-driven elements. As a result, traditional regulatory pathways often struggle to keep pace. This call supports projects that improve or redefine the methodologies, metrics and evidence used to evaluate innovative technologies across their full lifecycle, from early design and clinical evaluation to post-market surveillance.
Expected outcomes include:
- Better evidence-driven methodologies for regulators and policymakers to assess new technologies.
- Faster and more efficient uptake of safe, effective and patient-centred innovations in clinical practice.
To fulfil these outcomes in the long term, proposals must aim to update the regulatory science that underlie health technology legal frameworks for, among others, closing existing gaps concerning sufficiency of clinical evidence and the consideration of novel biomedical approaches, data and digital solutions.
Advancing evidence, innovation and uptake in regulatory science
Proposals can address any type of health technology (medical devices, in vitro diagnostics, AI-based systems, or Substances of Human Origin) and are expected to address either, or a combination of:
- The improvement of existing methodologies and their fitness to specific types or classes of health technologies, including methodology for regulatory assessment, and
- Explore and examine to what extent novel information sources, as indicated above can be considered as evidence that is satisfactory in view of regulatory needs concerning safety and performance.
Tip: Clarify the regulatory value of your approach. For instance, demonstrate how digital twins or AI models could improve clinical study design, predict safety outcomes or reduce reliance on animal testing, while meeting regulatory standards.
A key aim of this call is to help regulatory frameworks accommodate hybrid and cross-domain technologies that no longer fit traditional categories. This includes AI-enabled devices, bio-digital interfaces or products combining diagnostics and therapeutics. To fulfil this aim, the proposed work should address one or more of the following elements:
1. Refining existing approaches in regulatory science: Projects should generate data and analyses on how current regulatory methodologies can be refined and improved to close existing gaps in clarity and sufficiency of clinical evidence. This includes evidence generated through clinical studies and investigations to ensure that regulatory requirements are clear, efficient and aligned with technological progress.
2. Exploring novel information sources for clinical evaluation: Projects should produce data and analyses on whether and to what extent new sources of evidence from biomedicine, digital models and AI-enabled tools can contribute to the clinical evaluation of innovative health technologies. This may involve:
3. Supporting uptake of innovations through dedicated pathways: Projects should collect data and analyses to determine how the above approaches can accelerate the development and uptake of innovative technologies addressing unmet medical needs and special patient populations (e.g. paediatric or rare conditions). This may include the use of dedicated regulatory pathways or structured frameworks that allow testing and validation in real-world settings under regulatory supervision, such as a “regulatory sandbox”.
Please note that the actual conduct of clinical studies is not in scope of this call topic.
Tip: Show how your proposal bridges gaps between different regulatory domains, for example, between medical devices, diagnostics, AI systems and biologics. Mapping where existing frameworks overlap or conflict will help demonstrate your project’s added value. Highlight how your results could inform new regulatory guidance, standards or pathways that enable faster and safer uptake of complex, hybrid health technologies.
Navigating hybrid innovations and evolving EU frameworks
As health innovations increasingly combine digital, biological and mechanical components, hybrid technologies are becoming the new normal. However, existing technology-specific regulatory frameworks were not designed for such integrated products, leaving developers and regulators without a clear path to bring these innovations safely and efficiently to market. When considering an innovation, applicants should consider all relevant legislative frameworks, including the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), the proposed SoHO Regulation, and the AI Act, among others. Additionally, Proposals are encouraged to consider, where relevant, the data, expertise and services offered by European research infrastructures, especially those active in the health domain, such as EATRIS ERIC, and also the findings of previous EU projects.
Tip: Explain how your project will help interpret or apply these frameworks to new technology classes. Reference past EU projects and how your project will make use of existing infrastructures to show that your proposal will build rather than duplicate existing knowledge.
Designing for collaboration and credibility
This topic requires broad stakeholder involvement. The EC expects consortia to include regulators, notified bodies, clinical societies, academia, industry and patients. Collaboration between these actors ensures that proposed methodologies are both scientifically sound and practically relevant.
Tip: Engage regulators or notified bodies early, even in an advisory role. Their feedback strengthens credibility and alignment with real regulatory needs. Include patient organisations to ensure that innovation remains centred on clinical benefit and patient trust.
Looking for proposal writing support?
Since our foundation, we have been collaborating with more than 1,000 organisations in Europe and beyond. Our track record includes the Horizon Health RIAs EDiHTA, which develops evidence-based methodologies for assessing digital health technologies. This experience gives us first-hand insight into the challenges of generating, validating and integrating new types of evidence into regulatory and policy frameworks. In addition, we are partners in other Health RIAs such as EXPOSIM, EU PAL-COPD, GLIOMATCH, GENEGUT, COVend and MyPath. Additionally, our support extends to many more health-focused ITNs, including MITGEST and MobiliTraIN, as well as Pathfinder-Open projects related to health, such as POLINA and BoneOscopy.
The HORIZON-HLTH-2026-01-IND-03 call offers a unique opportunity to modernise Europe’s regulatory science ecosystem and ensure that innovation reaches patients safely and efficiently. Are you ready to embark on this exciting journey? Get in touch to see how our team of experts can support you!
