European UnionDeadline PassedNon-profit, Private Business, Research Institution, Public Institution, Other
Facilitating the conduct of multinational clinical studies of orphan devices and/or of highly innovative (“breakthrough”) devices
Horizon Europe Health Cluster - Maintaining an innovative, sustainable, and competitive EU health industry
Funding Amount
€6.0M - €8.0M
Deadline
16/09/2025
Eligible Organization Types
Non-profit, Private Business, Research Institution, Public Institution, Other
Trusted by
What is the Facilitating the conduct of multinational clinical studies of orphan devices and/or of highly innovative (“breakthrough”) devices Call?
Grant Description
Support multinational clinical studies of orphan devices and highly innovative breakthrough devices, including digital and AI-based tools, to generate clinical safety and performance data for CE marking. Addresses challenges in rare disease device development by enabling healthcare providers to access novel devices, collecting robust evidence, benefiting patients, and strengthening EU companies’ market positions.
Required Results for Successful Funding
Expected Outcomes
Proposals should deliver results that contribute to one or more of the following outcomes under the destination “Maintaining an innovative, sustainable, and competitive EU health industry”:
• Healthcare providers gain hands-on experience in the clinical use of orphan and/or highly innovative devices and secure timely access to devices with demonstrated clinical benefits.
• Device developers and manufacturers collect and obtain robust scientific evidence on the safety, performance and clinical benefits of their investigational device.
• Patients benefit from the development, clinical evaluation and use of orphan and/or highly innovative devices, leading to improved diagnostic, preventive or therapeutic options.
• Companies in the EU and Associated Countries strengthen their market position, build expertise in multinational clinical study design and conduct, and enhance competitiveness in the field of advanced medical devices.
• Healthcare providers gain hands-on experience in the clinical use of orphan and/or highly innovative devices and secure timely access to devices with demonstrated clinical benefits.
• Device developers and manufacturers collect and obtain robust scientific evidence on the safety, performance and clinical benefits of their investigational device.
• Patients benefit from the development, clinical evaluation and use of orphan and/or highly innovative devices, leading to improved diagnostic, preventive or therapeutic options.
• Companies in the EU and Associated Countries strengthen their market position, build expertise in multinational clinical study design and conduct, and enhance competitiveness in the field of advanced medical devices.
Funded areas
Scope Requirements
Proposals must address multinational clinical studies of orphan devices (intended for conditions affecting ≤12,000 EU patients/year with insufficient alternatives or expected benefit over state-of-the-art) and/or highly innovative (“breakthrough”) devices (addressing unmet medical needs, providing major clinical benefit for life-threatening, seriously debilitating or chronic conditions), including digital and AI-based tools. Key requirements:
• Study setting: pre- or post-market or development stage, minimum one device, conducted in at least two EU or Associated Countries, supporting CE marking under MDR or IVDR.
• Rigorous feasibility plan: patient selection, site recruitment, intersectional approach, supported by scientific publications or preliminary data.
• Inclusion of SSH expertise to account for socio-cultural determinants and maximise societal impact.
• Patient and stakeholder engagement: patients, carers, healthcare professionals involved in study design.
• Evidence generation: robust clinical evidence on safety, performance and patient-relevant outcomes (quality of life, patient-reported outcomes).
• Regulatory engagement: clear strategy for interaction with EMA, national regulators, HTA bodies, and plan for study authorisations by multiple competent authorities.
• Documentation of good practices and lessons learned from multinational trial conduct, with actionable recommendations.
• SME involvement is strongly encouraged.
• Proposals should plan synergies with ERDERA and EU4Health and may include multiple devices but must cover at least one.
• Study setting: pre- or post-market or development stage, minimum one device, conducted in at least two EU or Associated Countries, supporting CE marking under MDR or IVDR.
• Rigorous feasibility plan: patient selection, site recruitment, intersectional approach, supported by scientific publications or preliminary data.
• Inclusion of SSH expertise to account for socio-cultural determinants and maximise societal impact.
• Patient and stakeholder engagement: patients, carers, healthcare professionals involved in study design.
• Evidence generation: robust clinical evidence on safety, performance and patient-relevant outcomes (quality of life, patient-reported outcomes).
• Regulatory engagement: clear strategy for interaction with EMA, national regulators, HTA bodies, and plan for study authorisations by multiple competent authorities.
• Documentation of good practices and lessons learned from multinational trial conduct, with actionable recommendations.
• SME involvement is strongly encouraged.
• Proposals should plan synergies with ERDERA and EU4Health and may include multiple devices but must cover at least one.
Additional Conditions for Applicants
Special Conditions
• Two-stage submission: Stage 1 deadline 16 September 2025 (blind evaluation pilot), Stage 2 deadline 16 April 2026.
• Funding model: HORIZON Research and Innovation Action, lump sum grant (6–8 M EUR per project) under HORIZON-AG-LS rules.
• Blind evaluation in Stage 1: Part B must omit organisation names, acronyms, logos and personnel names.
• Eligibility restrictions: legal entities established in China and entities assessed as high-risk suppliers of mobile network equipment are ineligible; US entities are eligible; JRC participation possible post-award; Copernicus/Galileo/EGNOS use required for EO-based projects.
• Compliance with admissibility (Annex A/E), eligibility (Annex B) and financial/operational capacity (Annex C) conditions from the WP General Annexes.
• Page limits and layout as specified in the Application Form in the submission system.
• Use of Simplified Costs Decision for lump sum budgeting and compliance with Model Grant Agreement (Annex G).
• Mandatory use of the clinical study annex template for study details.
• Funding model: HORIZON Research and Innovation Action, lump sum grant (6–8 M EUR per project) under HORIZON-AG-LS rules.
• Blind evaluation in Stage 1: Part B must omit organisation names, acronyms, logos and personnel names.
• Eligibility restrictions: legal entities established in China and entities assessed as high-risk suppliers of mobile network equipment are ineligible; US entities are eligible; JRC participation possible post-award; Copernicus/Galileo/EGNOS use required for EO-based projects.
• Compliance with admissibility (Annex A/E), eligibility (Annex B) and financial/operational capacity (Annex C) conditions from the WP General Annexes.
• Page limits and layout as specified in the Application Form in the submission system.
• Use of Simplified Costs Decision for lump sum budgeting and compliance with Model Grant Agreement (Annex G).
• Mandatory use of the clinical study annex template for study details.
Important dates
Open from: 22/05/2025
Deadline:16/09/2025
Application period has ended
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