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  1. An institution, body, office or agency established by or based on the Treaty on European Union and the Treaties establishing the European Communities.

    All education and training facilities for people of different age groups.

    An intergovernmental organization having legal personality under public international law or a specialized agency established by such an international organization. An international organization, the majority of whose members are Member States or Associated Countries and whose main objective is to promote scientific and technological cooperation in Europe, is an International Organization of European Interest.

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  1. Administration & Governance, Institutional Capacity & Cooperation 

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Call key data

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

Funding Program

Horizon Europe: Cluster 1 - Health

Call number

HORIZON-HLTH-2026-01-IND-03

deadlines

Opening
10.02.2026

Deadline
16.04.2026 17:00

Funding rate

100%

Call budget

€ 19,600,000.00

Estimated EU contribution per project

between € 4,000,000.00 and € 6,000,000.00

Link to the call

ec.europa.eu

Link to the submission

ec.europa.eu

Call content

short description

The development, uptake and impact of health technologies typically results from a long product development process that is based on a 'life cycle approach' which typically involves several iterations of defined stages, i.e. from development, assessment to post-market surveillance and post-market clinical follow-up.

Call objectives

While health technologies are governed by comprehensive legal frameworks aiming to ensure that health technologies are safe and effective, the regulatory science underlying these legal frameworks needs to be updated. This concerns inter alia i) more precise delineation of specific requirements (e.g. closing existing gaps concerning sufficiency of clinical evidence) and ii) the consideration of novel biomedical approaches, data and digital solutions (e.g. artificial intelligence - AI, virtual human twin, new approach methodologies as well as methods that cut through these domains) which model and predict relevant biological parameters and exploit relevant end-points and novel (bio)markers for clinical diagnostic and prognostic predictions. Such update of the regulatory science of health technologies should aim at supporting an effective adoption and uptake into routine use by health systems and end-users (healthcare providers, citizens), while maintaining guardrails to ensure that innovative health technologies are backed up 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 with a focus on safety and performance throughout their lifecycle, i.e. throughout the continuous process of clinical evaluation. To this end, proposals should address either, or a combination of the following: i) the improvement of existing methodologies and their fitness to specific types or classes of health technologies, including methodology for regulatory assessment and ii) explore and examine to which extent novel information sources as indicated above can be considered as evidence that is satisfactory in view of regulatory needs concerning safety and performance.

Proposals should support the update and refinement of regulatory science on health technologies and contribute actionable information that can be used for improved or novel regulatory policies, rules, guidance documents and other tools with a view to ensuring that European patients and healthcare professionals have access to safe and effective innovative health technologies. Proposals should ultimately contribute to a regulatory environment that makes use of 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, facilitating the timely entry to market of performant and effective innovations and support their uptake in the health systems and clinical workflows without compromising patient safety.

Applicant consortia should reflect a broad representation of stakeholders, notably clinical societies, academia, notified bodies, industry, patients and regulators and 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 in view of closing existing gaps of clarity, sufficiency of clinical evidence, generated on the basis of clinical studies and clinical investigations.
  • Data and analyses on whether and to which 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, e.g.:
    • By providing information on relevant biophysical, anatomical, physiological and other disease-relevant aspects.
    • By supporting information integration through the use and aggregation of already existing data, including clinical ones, from similar types or groups of technologies (e.g. retrospective information in registries, data collections, including Real-World Data (RWD) from using technologies that have characteristics that are relevant for innovative technologies).
    • By supporting improved planning and design of first-in-man clinical studies, with a view of enhancing the effectiveness and the safety of such studies and rationalising the use of resources of all involved actors by focusing the generation and assessment of clinical data on health technologies for which those data are indispensable.
  • Data and analyses that examine to which extent the above-mentioned points can support the development and uptake of innovative technologies for unmet medical needs and for 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 in scope of this topic.

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

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

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 (e.g.: CORE-MD).

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Expected results

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable, and competitive EU health industry”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to several of 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.

Eligibility Criteria

Regions / countries for funding

Candidate Countries, EU Member States, Eastern Partnership, Overseas Countries and Territories (OCT)
Faeroes (Føroyar / Færøerne), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Liechtenstein, Morocco (المغرب), Norway (Norge), Switzerland (Schweiz/Suisse/Svizzera), Tunisia (تونس /Tūnis), United Kingdom

eligible entities

EU Body, Education and training institution, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)

Mandatory partnership

Yes

Project Partnership

To be eligible for funding, applicants must be established in one of the following countries:

  • the Member States of the European Union, including their outermost regions: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.
  • the Overseas Countries and Territories (OCTs) linked to the Member States: Aruba (NL), Bonaire (NL), Curação (NL), French Polynesia (FR), French Southern and Antarctic Territories (FR), Greenland (DK), New Caledonia (FR), Saba (NL), Saint Barthélemy (FR), Sint Eustatius (NL), Sint Maarten (NL), St. Pierre and Miquelon (FR), Wallis and Futuna Islands (FR).
  • countries associated to Horizon Europe; Albania, Arab Republic of Egypt, Armenia, Bosnia and Herzegovina, Canada, Faroe Islands, Georgia, Iceland, Israel, Kosovo, Moldova, Montenegro, New Zealand, North Macedonia, Norway, Republic of Korea, Serbia, Switzerland, Tunisia, Türkiye, Ukraine, United Kingdom. Other third countries may become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement.
  • the following low- and middle-income countries: Afghanistan, Algeria, Angola, Argentina, Azerbaijan, Bangladesh, Belarus, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, Colombia, Comoros, Congo (Democratic Republic), Congo (Republic), Costa Rica, Côte d'Ivoire, Cuba, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt (Arab Republic), El Salvador, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Fiji, Gabon, Gambia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, Indonesia, Iran (Islamic Republic), Iraq, Jamaica, Jordan, Kazakhstan, Kenya, Kiribati, Korea (Democratic People's Republic), Kyrgyz Republic, Lao (People’s Democratic Republic), Lebanon, Lesotho, Liberia, Libya, Madagascar, Malawi, Malaysia, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia (Federated States), Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Niue, Pakistan, Palau, Palestine, Papua New Guinea, Paraguay, Peru, Philippines, Rwanda, Samoa, São Tomé and Principe, Senegal, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, St. Lucia, St. Vincent and the Grenadines, Sudan, Suriname, Syrian Arab Republic, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tonga, Turkmenistan, Tuvalu, Uganda, Uzbekistan, Vanuatu, Venezuela (Bolivarian Republic), Vietnam, Yemen Republic, Zambia, Zimbabwe.
  • 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.

Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call/topic conditions, or if their participation is considered essential for implementing the action by the granting authority.

Any legal entity, regardless of its place of establishment, including legal entities from non associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call/topic.

A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.

Unless otherwise provided for in the specific call/topic conditions, only legal entities forming a consortium are eligible to participate in actions provided that the consortium includes, as beneficiaries, three legal entities independent from each other and each established in a different country as follows:

  • at least one independent legal entity established in a Member State; and
  • at least two other independent legal entities, each established in different Member States or Associated Countries.

As affiliated entities do not sign the grant agreement, they do not count towards the minimum eligibility criteria for consortium composition (if any).

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 criteria

Specific cases

Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.

Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any specific call/topic conditions.

Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.

EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.

International organisations — International European research organisations are eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’ actions or when provided for in the specific call/topic conditions. Other international organisations are not eligible to receive funding, unless provided for in the specific call/topic conditions, or if their participation is considered essential for implementing the action by the granting authority.

Joint Research Centre (‘JRC’) — Where provided for in the specific call/topic conditions, applicants may include in their proposals the possible contribution of the JRC, but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.

Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate either as beneficiaries or as affiliated entities (otherwise their costs will NOT be eligible).

EU restrictive measures — Entities subject to EU restrictive measures under Article 29 of the Treaty on the European Union (TEU) and Article 215 of the Treaty on the Functioning of the EU (TFEU) as well as Article 75 TFEU, are not eligible to participate in any capacity, including as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any).

Legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine — Given the illegal invasion of Ukraine by Russia and the involvement of Belarus, there is currently no appropriate context allowing the implementation of the actions foreseen in this programme with legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine. Therefore, even where such entities are not subject to EU restrictive measures, such legal entities are not eligible to participate in any capacity. This includes participation as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any). Exceptions may be granted on a case-by-case basis for justified reasons.

With specific regard to measures addressed to Russia, following the adoption of the Council Regulation (EU) 2024/1745 of 24 June 2024 (amending Council Regulation (EU) No 833/2014 of 31 July 2014) concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine, legal entities established outside Russia whose proprietary rights are directly or indirectly owned for more than 50% by a legal person, entity or body established in Russia are also not eligible to participate in any capacity.

Measures for the protection of the Union budget against breaches of the principles of the rule of law in Hungary — Following the Council Implementing Decision (EU) 2022/2506, as of 16 December 2022, no legal commitments can be entered into with Hungarian public interest trusts established under the Hungarian Act IX of 2021 or any entity they maintain. Affected entities may continue to apply to calls for proposals and can participate without receiving EU funding, as associated partners, if allowed by the call conditions. However, as long as the Council measures are not lifted, such entities are not eligible to participate in any funded role (beneficiaries, affiliated entities, subcontractors, recipients of financial support to third parties, etc.). In the case of multi-beneficiary grant calls, applicants will be invited to remove or replace that entity in any funded role and/or to change its status into associated partner. Tasks and budget may be redistributed accordingly.

Additional information

Topics

Digitalisation, Digital Society, ICT, 
Health, Social Services, Sports

Relevance for EU Macro-Region

EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region

UN Sustainable Development Goals (UN-SDGs)

Additional Information

Applications must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.

Applications must be submitted using the forms provided inside the electronic submission system (not the templates available on the topic page, which are only for information). The structure and presentation must correspond to the instructions given in the forms.

Applications must be complete and contain all parts and mandatory annexes and supporting documents.

Applications must include a plan for the exploitation and dissemination of results including communication activities, unless provided otherwise in the specific call/topic conditions. The plan is not required for applications at the first stage of two-stage procedures. If the expected exploitation of the results entails developing, creating, manufacturing and marketing a product or process, or in creating and providing a service, the plan must include a strategy for such exploitation. If the plan provides for exploitation of the results primarily in non-associated third countries, the applicants must explain how that exploitation is to be considered in the EU’s interest.

The application form will have two parts:

  • Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
  • Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.

Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).

The limit for a full application (Part B) is 45 pages.

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).

The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.

Call documents

Horizon Europe Work Programme 2026-2027 Cluster 1 - HealthHorizon Europe Work Programme 2026-2027 Cluster 1 - Health(1700kB)

Contact

National Contact Points for Horizon Europe
Website

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