Portable and versatile Point-of-care diagnostics

Overview

Funding for the development and optimization of portable, versatile point-of-care (PoC) diagnostic devices that improve clinical decision-making, patient outcomes, and health system efficiency. Targets researchers, healthcare innovators, and industry partners addressing diagnostic challenges in infectious and non-communicable diseases, particularly in resource-limited settings.

Who Can Apply

Legal entities established in eligible countries, including EU Member States, Associated Countries, and the United States. Consortia are expected, with participation open to universities, research institutions, SMEs, industry, and healthcare providers. Entities directly or indirectly controlled by China are excluded.

Funding Details

Maximum grant amount: €10,000,000 per project. Funding is provided as a lump sum, with eligible costs determined by the Horizon Europe lump sum model.

What Is Funded

• Optimization of PoC diagnostic devices meeting WHO REASSURED criteria (e.g., real-time connectivity, affordability, sensitivity, user-friendliness, and deliverability).
• Comparative studies demonstrating improved performance over existing solutions.
• Clinical validation and conformity assessment under EU In-Vitro Medical Device (IVDR) or Medical Device (MDR) regulations.
• Integration of mobile technologies, AI/ML algorithms, and sample-to-answer capabilities.
• Approaches prioritizing resource-limited settings, emergency diagnostics, or pathogen differentiation (viral, bacterial, fungal).

Technology / Maturity Requirements

Projects must target Technology Readiness Levels (TRL) 4 to 6, focusing on prototype development, validation, and early clinical testing.

Key Dates

• Open date: 2027-02-09
• Deadline: 2027-04-12

Application Process (High-Level)

Two-stage evaluation process: 1. First stage (blind evaluation): Submission of an anonymized proposal (no organization names, logos, or personnel details). Thresholds: 4/5 for Excellence and Impact. 2. Second stage: Invited applicants submit full proposals, including clinical study details if applicable. Thresholds: 4/5 for Excellence, Impact, and Implementation (cumulative threshold: 12/15).

Applications must be submitted via the Funding & Tenders Portal.

Post-Award Obligations

• Compliance with Horizon Europe reporting requirements, including financial and technical progress.
• Dissemination of results and potential restrictions on ownership transfers or exclusive licensing for up to 4 years post-project.
• Adherence to EU regulatory frameworks (IVDR/MDR) for medical devices.

Geographic Scope & Language

Eligible countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Norway, Iceland, United Kingdom, Switzerland. Application language: English.

Notes

• Proposals must include a clinical needs assessment and value-based concept aligned with Health Technology Assessment (HTA) requirements.
• Priority given to solutions addressing resource-limited settings or emergency diagnostics.
• Use of Copernicus/Galileo data required if satellite-based services are involved.
• First-stage proposals must comply with blind evaluation rules (no identifying information).