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Horizon Europe
2 phases
Strategic Analysis
This call presents a strategic opportunity to advance the clinical validation of orphan and highly innovative medical devices through robust, multinational studies. Winning proposals will demonstrate a clear pathway to patient benefit and market access, integrating patient-centric design, social sciences and humanities (SSH) expertise, and a proactive regulatory strategy to reinforce Europe's leadership in breakthrough health technologies.
TRL 2 → 6
Based on programme defaults
Design and conduct multinational clinical studies in a minimum of two different countries in the EU or Associated Countries, with a focus on orphan devices and/or highly innovative (“breakthrough”) devices, with a view to demonstrate the safety and clinical performance of the device(s) subject to the study.
Present a sound clinical study feasibility plan, including an appropriate patient selection and realistic recruitment plans at different sites, justified by scientific publications or preliminary results. Proposals should adopt a gender-sensitive and intersectional approach, considering individual characteristics such as gender, sex, race, ethnicity, disability and age. Additionally, socioeconomic, lifestyle and behavioural factors should be taken into account. For this, the topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.
Demonstrate potential clinical benefit [6] for patients and healthcare providers, including quality of life and consideration of patient-reported outcomes when relevant.
Involve patients, patient organisations, carers and healthcare professionals in the design of the clinical studies.
Identify, collect and record relevant good practices and experiences related to the design, conduct, sample handling, data analysis and results reporting of multinational clinical studies. In addition, provide appropriate recommendations and lessons learned.
For multinational clinical studies, authorisation for the study approval by more than one national competent authority may be necessary. Develop a regulatory strategy and interaction plan for generating appropriate evidence as well as engaging with regulators and other relevant bodies (e.g., European Medicines Agency (EMA), EMA expert panels [7] , national regulators, Health Technology Assessment bodies, etc.) in a timely manner. Consider also the potential for future regulatory impact of the results.
Healthcare providers increase their hands-on experience regarding the clinical use of orphan devices [1] and/or of highly innovative (“breakthrough”) devices and get timely access to such devices with demonstrated clinical benefits;
Developers and manufacturers collect and obtain scientific evidence on their proposed intervention/ approach with the device under investigation;
Patients benefit from the development, studies and use of orphan devices and/or of highly innovative (“breakthrough”) devices;
Companies in the EU and associated countries get a better market position in this field and improve their knowledge on how to conduct multinational clinical studies for these devices.
Health industry in Europe and Associated Countries is more competitive and sustainable, assuring European leadership in breakthrough health technologies and open strategic autonomy in essential medical supplies and (digital) technologies, contributing to job creation and economic growth, in particular with small and medium-sized enterprises (SMEs).
Health industry is supported by cross-sectoral Research and Innovation in the context of convergence of health technologies (integrating medical technologies, pharmaceuticals, biotechnologies, digital health, and e-health technologies) while strengthening key market positions.
Health industry is working more efficiently along the value chain from the identification of needs to the scale-up and take-up of solutions at national, regional or local level, including through early engagement with patients, healthcare providers, health authorities and regulators ensuring suitability and acceptance of solutions.
Citizens, healthcare providers and health systems benefit from a swift uptake of innovative health technologies and services through the provision of evidence and guidelines for stakeholders, policymakers and regulators. These efforts offer significant improvements in health outcomes, also potentially strengthening access to healthcare for all and reducing health inequities while health industry benefits from decreased time-to-market.
Citizens, healthcare providers and health systems benefit from increased health security in Europe and Associated Countries due to reliable access to key manufacturing capacity, including timely provision of essential medical supplies and technologies of particularly complex or critical supply and distribution chains.
EU Industrial Policy
highThe EU Industrial Policy aims to strengthen the competitiveness, resilience, and strategic autonomy of European industries. It focuses on fostering innovation, supporting the green and digital transitions, creating a favourable business environment, and ensuring the EU's global leadership in key technologies and strategic sectors. The policy seeks to address challenges and opportunities for all types of businesses, including SMEs.
Evaluators expect proposals to demonstrate how they contribute to the competitiveness and resilience of the EU's medical device industry, particularly in the context of innovative and breakthrough devices. This could involve streamlining regulatory processes, fostering R&D, attracting investment, and ensuring the EU remains a leader in medical technology. Proposals should highlight collaboration with industry, SMEs, and research institutions to accelerate market access for innovative devices and strengthen the EU's industrial base.
Digital Single Market strategy
highThe Digital Single Market (DSM) strategy aims to break down barriers to cross-border digital activity in the EU, ensuring the free movement of goods, services, data, and capital in the digital realm. It focuses on improving access to digital goods and services, creating the right conditions for digital networks and services to flourish, and maximizing the growth potential of the digital economy across the Union.
Proposals should demonstrate how they leverage digital tools, infrastructure, and data solutions to facilitate multinational clinical studies. This could include the use of digital platforms for secure data sharing, e-health solutions, AI-driven analytics for trial design or patient recruitment, or efficient cross-border data exchange for clinical trial management. Emphasis on interoperability, robust cybersecurity, and compliance with EU data protection regulations (such as GDPR) will be crucial for evaluators.
Regulations on Medical Devices (MDR)
highThe Medical Device Regulation (EU) 2017/745 significantly strengthens the regulatory framework for medical devices in the EU. It aims to ensure a high level of health and safety protection for patients and users, while supporting innovation. Key aspects include stricter pre-market scrutiny, enhanced post-market surveillance, improved transparency, and clearer responsibilities for economic operators.
Proposals must explicitly demonstrate a thorough understanding of and compliance with the MDR requirements, particularly concerning clinical investigations, performance evaluation, and post-market surveillance for innovative and breakthrough devices. This includes addressing the challenges of conducting multinational clinical studies under the MDR, such as harmonizing ethical approvals, data collection, and reporting across different Member States. Proposals should outline strategies to navigate the regulatory landscape efficiently while ensuring patient safety and data integrity.
Regulations on In Vitro Diagnostic Medical Devices (IVDR)
highThe In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 replaces the previous IVD Directive, introducing a more robust, transparent, and sustainable regulatory framework for IVD medical devices. It aims to ensure a high level of public health protection by enhancing patient safety, improving clinical evidence requirements, and strengthening post-market surveillance for IVDs.
Proposals should demonstrate awareness of the IVDR if their 'devices' include in vitro diagnostics. They should address how the specific requirements for performance studies, clinical evidence, and post-market surveillance under the IVDR will be met, especially in a multinational context. Strategies for navigating the regulatory complexities for innovative IVDs, ensuring data quality, and compliance across different EU Member States will be important.
Pharmaceutical Strategy for Europe
lowThe Pharmaceutical Strategy for Europe aims to ensure access to affordable, innovative, and safe medicines while supporting the competitiveness and sustainability of the EU pharmaceutical industry. It addresses challenges such as antimicrobial resistance, medicine shortages, and the need for patient-centric innovation. The strategy also promotes digital transformation and regulatory modernization in the pharmaceutical sector.
Evaluators expect proposals to address low-value pharmaceutical care, such as overprescribing, inappropriate use of medicines, or inefficiencies in drug procurement and distribution. Proposals should demonstrate how they align with the strategy’s goals of improving affordability, accessibility, and sustainability in pharmaceutical care. Evidence of collaboration with stakeholders (e.g., healthcare providers, regulators, industry) and a focus on patient outcomes will strengthen the proposal.
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Applicants submitting a proposal under the blind evaluation pilot (see General Annex F) must not disclose their organisation names, acronyms, logos nor names of personnel in the proposal abstract and Part B of their first-stage application (see General Annex E).
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.
The Joint Research Centre (JRC) may participate as member of the consortium selected for 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).
The following exceptions apply: subject to restrictions for the protection of European communication networks.
Other Eligible 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.
This topic is part of the blind evaluation pilot under which first stage proposals will be evaluated blindly.
Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
For the first stage, the thresholds for each criterion will be 4 (Excellence) and 4 (Impact). The overall threshold applying to the sum of the two individual scores will be set at a level that ensures the total requested budget of proposals admitted to stage 2 is as close as possible to four times the available budget, and not less than three and a half times the available budget.
For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.
Evaluation and award: Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Evaluation and award: Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
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) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].
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.
Application and evaluation form templates
Standard application form (HE RIA IA Stage 1) - the application form specific to this call is available in the Submission System
Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System
Standard evaluation form (HE RIA, IA and CSA Stage 1) - will be used with the necessary adaptations
Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations
Guidance
Model Grant Agreement (MGA)
Call-specific instructions
Information on clinical studies (HE)
Guidance: "Lump sums - what do I need to know?"
HE Main Work Programme 2025 – 1. General Introduction
HE Main Work Programme 2025 – 4. Health
HE Main Work Programme 2025 – 14. General Annexes
HE Framework Programme 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation 2024/2509
Decision authorising the use of lump sum contributions under the Horizon Europe Programme
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Evaluators will primarily scrutinize the scientific excellence and feasibility of the proposed multinational clinical study, particularly its methodological rigor for orphan and/or breakthrough devices. They will pay close attention to the genuine involvement of patients and healthcare professionals (@SC4), the integration of gender-sensitive and intersectional approaches with effective SSH contributions (@SC2), and a well-defined regulatory strategy (@SC6) that promises to accelerate the uptake of innovative solutions and reduce health inequities.
The AI has drafted potential core elements based on the call analysis. To start building your project proposal structure, select the elements that resonate with your consortium's concept. You can refine and rewrite them fully once your project workspace is created.
The scarcity of robust, multinational clinical data for orphan and breakthrough medical devices hinders their timely approval, market access, and subsequent patient benefit, perpetuating unmet medical needs.
Designing and conducting multinational clinical studies that effectively incorporate gender-sensitive, intersectional approaches, and genuine patient involvement is complex, leading to studies that may not fully address diverse patient needs or achieve optimal societal impact.
Navigating the diverse and often fragmented regulatory requirements across multiple EU and Associated Countries for novel medical devices creates significant hurdles, delaying study approvals and patient access to innovative therapies.
A lack of systematic identification, collection, and dissemination of good practices and lessons learned from multinational clinical studies impedes the efficiency and quality of future research and development in the medical device sector.
Individuals suffering from conditions treatable by orphan or breakthrough devices, and the organisations representing their interests, who will benefit from improved access to innovative treatments and whose perspectives are crucial for study design.
Medical practitioners, nurses, and other healthcare staff who will gain hands-on experience with new devices and provide essential input for clinical study design, as well as informal carers supporting patients.
Companies, particularly Small and Medium-sized Enterprises (SMEs), involved in the research, development, and production of orphan and highly innovative medical devices, who need scientific evidence and regulatory guidance for market access.
National competent authorities, EMA, and HTA bodies responsible for the approval, assessment, and reimbursement of medical devices, who will interact with the project to facilitate regulatory pathways and evidence generation.
National and regional health systems and policymakers who will benefit from evidence-based guidelines, improved access to innovative technologies, and enhanced health security and equity for their populations.
Researchers and institutions providing expertise on gender-sensitive and intersectional approaches, crucial for understanding and addressing diverse patient needs and societal impacts in clinical studies.
To design and conduct rigorous multinational clinical studies demonstrating the safety and clinical performance of orphan and/or highly innovative medical devices, providing robust scientific evidence for their efficacy and potential clinical benefit for patients and healthcare providers.
To develop a sound clinical study feasibility plan that incorporates gender-sensitive and intersectional approaches, effectively involving social sciences and humanities (SSH) experts, and actively engaging patients, patient organisations, carers, and healthcare professionals in the study design to ensure relevance and acceptance.
To develop a comprehensive regulatory strategy and interaction plan for timely study approval and future market access, while identifying, collecting, and disseminating good practices and lessons learned from multinational clinical studies to improve efficiency and knowledge transfer across the health industry.
To facilitate increased hands-on experience for healthcare providers with orphan and/or highly innovative devices, ensuring timely access to these devices with demonstrated clinical benefits, thereby improving patient care and outcomes.
The project will strengthen the European health industry's competitiveness and leadership in breakthrough medical technologies, contributing to open strategic autonomy in essential medical supplies and fostering job creation and economic growth, particularly for SMEs.
Citizens, healthcare providers, and health systems will benefit from a swift uptake of innovative health technologies, leading to significant improvements in health outcomes, reduced health inequities, and strengthened access to healthcare for all.
The health industry will operate more efficiently along the value chain, from needs identification to solution uptake, through early engagement with stakeholders and a more streamlined regulatory environment, decreasing time-to-market for innovative devices.
Europe's health security will be enhanced through reliable access to key manufacturing capacity and timely provision of essential medical supplies and technologies, particularly those with complex or critical supply chains, contributing to strategic autonomy.