Call for proposals to modernize the regulatory science governing health technologies within the EU.

About this grant

Call for proposals to modernize the regulatory science governing health technologies within the EU. With a total budget of €19.60 million and awards ranging from €4.00 to €6.00 million, the initiative focuses on updating methodologies for clinical evaluation and regulatory assessment. The goal is to ensure that legal frameworks keep pace with rapid innovation in areas such as artificial intelligence (AI), virtual human twins, and new approach methodologies (NAMs), while maintaining rigorous safety and performance standards. Proposals should target the improvement of existing methodologies or explore how novel information sources can provide satisfactory evidence for regulatory needs. Key focus areas include: Refining Evidence Requirements: Closing gaps in clinical evidence clarity and sufficiency for medical devices, in-vitro diagnostics, and substances of human origin (SoHO); Integrating Digital & Bio-medical Approaches: Examining how AI-enabled models, Real-World Data (RWD), and disease-relevant biophysical data can support clinical investigations and predict biological parameters; Optimizing Study Design: Using existing data to improve the planning of first-in-human studies, thereby enhancing participant safety and rationalizing resource use; and Special Populations & Unmet Needs: Exploring regulatory pathways, such as regulatory sandboxes, to accelerate the uptake of technologies for rare diseases and pediatric conditions.

How to apply

1. 1Verify eligibility criteria, including applicant type (e.g., SMEs, consortia), geographic requirements, and funding rates (often 40-100% co-financing).
2. 2Form a consortium if required (e.g., minimum partners from multiple countries for collaborative projects).
3. 3Register as a user and your organization on the EU Funding & Tenders Portal to obtain a Participant Identification Code (PIC).
4. 4Download templates, prepare Part A (administrative data) and Part B (technical description, budget, impact), and run validation checks.
5. 5Submit online before the deadline; track via confirmation email and code, with evaluation taking 3-6 months.
6. 6Visit https://eufundingportal.eu for application details

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