Regulatory science to support translational development of patient-centred health technologies

The Horizon Europe opportunity titled HORIZON-HLTH-2026-01-IND-03 focuses on "Regulatory science to support translational development of patient-centred health technologies." This initiative is a HORIZON Research and Innovation Action (HORIZON-RIA), utilizing a HORIZON Lump Sum Grant model, aiming to enhance regulatory science methodologies aligned with health technology innovation.

The total budget for this topic is €19.6 million, with an expected 4 grants ranging from €4 million to €6 million each. The call is planned to open on February 10, 2026, with a submission deadline of April 16, 2026.

Eligible applicants include a wide range of entities such as academic institutions, healthcare organizations, industry participants, regulators, and patient advocacy groups. Notably, legal entities from the United States are also eligible for funding, promoting international collaboration.

The focus is on various sectors of healthcare including medical devices, in-vitro diagnostics, AI technologies, and substances of human origin. The primary goal is to refine regulatory science methods to ensure effective evaluation of health technologies, facilitating safer and more efficient clinical practices.

Proposals must address how existing regulatory methodologies can be improved, examine novel information sources for evidence, and support the development of innovative technologies addressing unmet medical needs. While not allowing clinical studies themselves, the initiative encourages the generation of data that enhances regulatory processes.

A consortium is mandated for applications to ensure a multidisciplinary approach, reflecting the expertise of clinical societies, academia, industry, patients, and regulators. The call emphasizes the importance of improving regulatory policies and methodologies while maintaining patient safety and the integrity of health systems.

Applicants will follow a single-stage submission process, with an evaluation framework based on criteria of excellence, impact, and implementation. Generally, success rates in similar funding initiatives tend to fall between 10% and 39%, highlighting a competitive selection process.

This opportunity represents a significant investment in modernizing the regulatory landscape for health technologies, aiming to facilitate faster, safer access to innovations for European patients and healthcare professionals.

This is a Horizon Europe (HORIZON) call, specifically within Cluster 1 Health (Single stage 2026) (HORIZON-HLTH-2026-01). The topic is Regulatory science to support translational development of patient-centred health technologies, with the topic ID HORIZON-HLTH-2026-01-IND-03. It is a HORIZON Research and Innovation Action (HORIZON-RIA) and uses the HORIZON Lump Sum Grant [HORIZON-AG-LS] Model Grant Agreement. It is a forthcoming call with a single-stage deadline model. The planned opening date is 10 February 2026, and the deadline date is 16 April 2026 at 17:00:00 Brussels time.

The expected outcome of this topic is to support activities that enable or contribute to several expected impacts of destination “Maintaining an innovative, sustainable, and competitive EU health industry”. Proposals should aim to deliver results that are directed at, tailored towards, and contributing to the following expected outcomes:

Policymakers and regulators will get accelerated access to improved evidence-driven methodologies to evaluate the impact and efficiency of novel health technologies, facilitating decision-making for their use in humans and uptake in clinical practice.

Patients and the health systems will benefit from the more targeted and efficient uptake of safe and effective health innovations in clinical practice, supporting more personalised approaches and improved care and public health.

The scope of this topic includes the following:

The development, uptake, and impact of health technologies typically result from a long product development process based on a 'life cycle approach,' involving several iterations of defined stages, from development and assessment to post-market surveillance and clinical follow-up.

While health technologies are governed by comprehensive legal frameworks to ensure safety and effectiveness, the regulatory science underlying these frameworks needs updating. This includes:

More precise delineation of specific requirements, such as closing existing gaps concerning the sufficiency of clinical evidence.

Consideration of novel biomedical approaches, data, and digital solutions, including artificial intelligence (AI), virtual human twins, new approach methodologies, and methods that cut through these domains. These solutions should model and predict relevant biological parameters and exploit relevant endpoints and novel (bio)markers for clinical diagnostic and prognostic predictions.

The update of regulatory science should support effective adoption and uptake into routine use by health systems and end-users (healthcare providers, citizens), while maintaining guardrails to ensure innovative health technologies are backed by evidence of sufficient quality and relevance to the human situation.

Proposals can cover all types of health technologies, aiming to define improved and novel sources of evidence with proven relevance for regulatory decision-making, focusing on safety and performance throughout their lifecycle. Proposals should address either or a combination of:

Improvement of existing methodologies and their fitness to specific types or classes of health technologies, including methodology for regulatory assessment.

Exploration and examination of the extent to which novel information sources can be considered satisfactory evidence for regulatory needs concerning safety and performance.

Proposals should support the update and refinement of regulatory science on health technologies and contribute actionable information for improved or novel regulatory policies, rules, guidance documents, and other tools. The goal is to ensure that European patients and healthcare professionals have access to safe and effective innovative health technologies. Proposals should ultimately contribute to a regulatory environment that uses the full spectrum of novel biomedical and bio-digital approaches for clinical investigation and evaluation, while promoting a patient-centred approach to health technology innovation. This facilitates the timely entry to market of performant and effective innovations and supports their uptake in health systems and clinical workflows without compromising patient safety.

Applicant consortia should reflect a broad representation of stakeholders, including clinical societies, academia, notified bodies, industry, patients, and regulators. The proposed work should address one or more of the following elements:

Data and analyses on how existing approaches in regulatory science can be refined and improved to close existing gaps in clarity and sufficiency of clinical evidence generated from clinical studies and investigations.

Data and analyses on whether and to what extent novel information sources from biomedicine, including new approach methods and digital and AI-enabled models and approaches, can contribute to the clinical evaluation of innovative health technologies. Examples include:

Providing information on relevant biophysical, anatomical, physiological, and other disease-relevant aspects.

Supporting information integration through the use and aggregation of existing data, including clinical data, from similar types or groups of technologies (e.g., retrospective information in registries, data collections, including Real-World Data (RWD) from using technologies with characteristics relevant for innovative technologies).

Supporting improved planning and design of first-in-man clinical studies to enhance effectiveness and safety and rationalise resource use by focusing the generation and assessment of clinical data on health technologies for which those data are indispensable.

Data and analyses that examine the extent to which the above points can support the development and uptake of innovative technologies for unmet medical needs and special patient populations (e.g., paediatric and rare conditions) via dedicated regulatory pathways and/or within a structured framework enabling their development and testing in a real-world environment under regulatory supervision (“regulatory sandbox”).

The actual conduct of clinical studies is not within the scope of this topic.

Activities should cover and draw on all relevant healthcare innovation-related frameworks other than pharmaceutical products, including medical devices, in-vitro diagnostics, AI, and Substances of Human Origin (SoHO).

The starting point is a good understanding of the innovative technology and its inherent risks, so appropriate safety and quality requirements can be applied for monitoring outcomes in the relevant healthcare setting. As the number of hybrid or combinations of health technologies increases and technology integration becomes the norm, the current segregated, technology-specific frameworks may not provide a clear path forward. Therefore, when considering an innovation, it is important to consider all relevant legislative frameworks, including MDR and IVDR, the proposed SoHO-Regulation, and the AI Act.

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 the findings of previous EU projects, such as CORE-MD.

Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form available in the Submission System. Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide. In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding. If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used). Subject to restrictions for the protection of European communication networks. Other eligibility conditions are described in Annex B of the Work Programme General Annexes. Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes. The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes. The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5. Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025). Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

The budget for this topic is 19,600,000 EUR for the year 2026. The contributions are expected to be between 4,000,000 and 6,000,000 EUR, and the indicative number of grants is 4.

The opening date is planned for 10 February 2026, and the deadline is 16 April 2026.

This Horizon Europe call aims to improve the regulatory science behind health technologies to ensure they are safe, effective, and innovative. It encourages projects that refine existing regulatory approaches and explore new data sources and digital tools for evaluating health technologies. The goal is to create a more efficient and patient-centered regulatory environment that supports the development and adoption of cutting-edge health solutions in Europe. Consortia applying for this funding should include a diverse group of stakeholders, including researchers, industry representatives, regulators, and patient groups. The call specifically excludes clinical trials but encourages the use of real-world data and consideration of various regulatory frameworks related to medical devices, AI, and other health-related technologies.

Eligible Applicant Types: The eligible applicant types are broad and include clinical societies, academia, notified bodies, industry, patients, and regulators. The applicant consortia should reflect a broad representation of these stakeholders. Furthermore, any legal entity established in the United States of America is eligible to receive Union funding. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects.

Funding Type: The funding type is a grant, specifically a HORIZON Research and Innovation Action (HORIZON-RIA) with a HORIZON Lump Sum Grant [HORIZON-AG-LS] Model Grant Agreement. There are also HORIZON Public Procurement of Innovative Solutions (HORIZON-PPI) and HORIZON Coordination and Support Actions (HORIZON-CSA).

Consortium Requirement: A consortium is required, and it should reflect a broad representation of stakeholders, including clinical societies, academia, notified bodies, industry, patients, and regulators.

Beneficiary Scope (Geographic Eligibility): Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. Any legal entity established in the United States of America is eligible to receive Union funding.

Target Sector: The target sector is health, specifically focusing on regulatory science to support the translational development of patient-centered health technologies. This includes medical devices, in-vitro diagnostics, AI, and Substances of Human Origin (SoHO).

Mentioned Countries: United States of America.

Project Stage: The project stage appears to be focused on development and refinement of regulatory science, with an emphasis on methodologies for regulatory assessment and exploring novel information sources for evidence. It aims to facilitate the timely entry to market of performant and effective innovations and support their uptake in the health systems and clinical workflows.

Funding Amount: The funding amounts vary depending on the specific topic. Some topics offer around 1,900,000 EUR, while others range from 3,000,000 to 8,000,000 EUR, 6,000,000 to 8,000,000 EUR, 9,000,000 to 11,000,000 EUR, or around 10,000,000 EUR.

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process is a single-stage process.

Success Rates: The success rates are not explicitly mentioned in the provided text.

Co-funding Requirement: The text does not explicitly mention a co-funding requirement.

Summary:

This Horizon Europe funding opportunity, under the Health cluster, aims to bolster the regulatory science surrounding health technologies to foster innovation and improve patient care. The focus is on updating regulatory frameworks to accommodate novel biomedical and bio-digital approaches, ensuring the safety and effectiveness of health technologies throughout their lifecycle. Eligible applicants include a wide array of stakeholders, such as clinical societies, academia, industry, patients, and regulators, who are expected to form consortia. The funding mechanism is primarily through Research and Innovation Actions (RIA) with lump sum grants, though other action types like Public Procurement of Innovative Solutions (PPI) and Coordination and Support Actions (CSA) are also available. The geographic scope is broad, including EU member states, associated countries, and the United States. The program targets health technologies, including medical devices, in-vitro diagnostics, AI, and Substances of Human Origin (SoHO), but excludes pharmaceuticals. Projects should focus on refining regulatory science, analyzing data, and supporting the development and uptake of innovative technologies, particularly for unmet medical needs and special patient populations. The application process involves a single-stage submission, with funding amounts varying based on the specific topic. The opportunity seeks to create a regulatory environment that promotes patient-centered innovation, facilitates market entry, and supports the integration of effective innovations into healthcare systems, all while maintaining patient safety. The call for proposals opens on February 10, 2026, and closes on April 16, 2026.