Call for proposals for a programme on orphan medical devices, in particular targeting paediatric patients

Grant Purpose and Target

• Core Objective: This action aims to support innovation and the development of orphan medical devices, particularly for paediatric patients, by funding non-profit platforms or consortia that connect academic bodies, SMEs, and NGOs to address unmet medical needs.
• Funding Organization: European Health and Digital Executive Agency (HaDEA).
• Target Recipients: Eligible applicants include non-profit organisations, academic bodies, scientific societies, developers of devices (in particular SMEs), and NGOs. Applications can be from a single non-profit organisation or a consortium.
• Sector Focus: SECTOR-SPECIFIC. The grant is focused on the healthcare sector, specifically the development of orphan medical devices.
• Geographic Scope: The call is open to legal entities established in EU Member States and countries associated with the EU4Health programme. As of the grant information, this includes Iceland, Norway, Ukraine, and Moldova.
• Key Filtering Criteria: Projects must focus on the development of innovative orphan medical devices, with a particular emphasis on paediatric patients and responding to unmet medical needs. The action supports the creation of platforms to foster and guide the development process from concept to CE marking.

Financial Structure

The legal and financial set-up is detailed in section 10 of the call document, which was not available for this analysis. The following is based on the provided data and standard EU grant practices.

• Funding Range: The minimum and maximum grant amount per project are not specified in the provided materials. The total available budget for this topic is EUR 1,200,000.
• Co-financing: The required co-financing percentage (and thus the funding rate) is not specified in the provided documents. EU4Health Action Grants typically offer a funding rate of 60%, which may be increased to 80% for actions deemed of 'exceptional utility'. The exact rate for this call can only be confirmed from the official call document.
• Eligible Costs: Costs must be directly linked to the action and necessary for its implementation. Based on the project scope, eligible costs may include:
  • Personnel costs: Staff involved in project management, research, and mentoring.
  • Subcontracting costs: For specific tasks outsourced to third parties.
  • Purchase costs: Including travel, accommodation, and costs for equipment (e.g., for prototyping), and other goods and services (e.g., for laboratory testing, IP advising, grant-writing services, dissemination materials).
  • Indirect costs: A 7% flat rate of the eligible direct costs is typically applied to cover general overheads, unless specified otherwise in the call document.
• Ineligible Costs: As per standard EU grant rules, ineligible costs include, but are not limited to:
  • Debt and debt service charges.
  • Provisions for losses or debts.
  • Interest owed.
  • Currency exchange losses.
  • Deductible VAT.
• Payment & Reporting: Payments are typically structured with an initial pre-financing, followed by one or more interim payments and a final payment of the balance. Each payment (except the initial pre-financing) is contingent on the submission and approval of a periodic report detailing technical progress and financial expenditure.

Eligibility Requirements

• Formal Criteria: As per the grant documentation, detailed eligibility criteria are described in section 6 of the call document, which was not provided for this analysis. Based on the available information, the following criteria apply:
  • Applicants must be legal entities (public or private bodies).
  • Applicants must be established in an eligible country (EU Member States or countries associated to the EU4Health programme).
  • Proposals must be submitted electronically via the EU Funding & Tenders Portal before the deadline.
• Organizational Status: Eligible applicants include non-profit organisations, academic bodies, scientific societies, small and medium-sized enterprises (SMEs) (as device developers), and NGOs. Applications can be submitted by a single non-profit organisation or by a consortium of eligible entities. For-profit entities like SMEs are expected to participate as part of a consortium.
• Technical Expertise: Applicants must demonstrate the capacity to foster and guide the development of orphan medical devices. This includes expertise in:
  • Mapping unmet medical needs.
  • Connecting innovators (academia, users) with manufacturers.
  • Mentoring and managing device development projects (product ID, prototyping, etc.).
  • Connecting developers to financing resources.
  • Assessing the scientific and medical merit of proposed projects.
  • Advising on regulatory requirements, particularly for CE marking under Regulation (EU) 2017/745 or 2017/746.
• Exclusion Criteria: Detailed exclusion criteria are described in section 7 of the call document. Standard EU grant exclusion criteria apply, including situations like bankruptcy, grave professional misconduct, fraud, and other legal infringements.

Application Practical Information

• Deadlines:
  • Opening Date: 23 September 2025
  • Submission Deadline: 06 January 2026, 00:00:00 UTC (Note: This is an unusual time; most EU deadlines are 17:00 Brussels time. Applicants should verify the exact time in the call document on the portal).
• Required Documents: Applicants must submit their proposal electronically via the EU Funding & Tenders portal. The submission includes:
  • Standard Application Form (EU4H) (Part A & Part B).
  • Detailed budget table (EU4H).
• Application Process: The call follows a single-stage submission procedure. All required documents must be submitted together by the deadline through the electronic submission service on the EU Funding & Tenders Portal.
• Support:
  • For call-related questions: [email protected].
  • For technical issues: IT Helpdesk available via the portal.
  • An Info Session recording and presentations are available via a link in the topic description.
  • The portal provides an Online Manual, FAQs, and other guidance documents.
• Post-Award Obligations: Successful applicants will be required to sign a Grant Agreement. Obligations include submitting periodic technical and financial reports, keeping detailed records for potential audits for up to 5 years after the final payment, and complying with communication and dissemination requirements.

Evaluation Criteria

The specific award criteria, scoring, and thresholds are described in section 9 of the call document, which was not provided for this analysis. However, based on the grant's stated objectives and scope, evaluation will likely focus on the following aspects:

• Scoring Factors: While not specified, EU grants are typically evaluated based on criteria such as Relevance, Quality of the implementation, and Impact.
• Innovation & Impact: The proposal's ability to promote the development of innovative orphan devices will be critical. A strong emphasis is placed on addressing unmet medical needs, especially for paediatric patients. The potential impact on public health and patient well-being is a key consideration.
• Project Quality: The quality and feasibility of the proposed activities will be assessed. This includes the methodology for:
  • Mapping unmet needs and connecting relevant stakeholders.
  • Mentoring and managing orphan device projects through the entire development process.
  • Providing advice on regulatory pathways, IP protection, and business development.
  • Gathering and evaluating pre-clinical data to support safety and performance.
• Strategic Fit: The project must align with the objectives of the EU4Health programme, specifically supporting innovation in the field of medical devices. The proposal should clearly demonstrate how it contributes to the call's goal of creating a supportive ecosystem for orphan device development.
• Cross-cutting Themes: The primary focus is on paediatric patients, which is a central theme of the call. Other cross-cutting themes like gender or environmental sustainability are not explicitly mentioned in the provided summary.

Compliance and Special Requirements

• Regulatory Compliance: A core activity of the projects funded under this call is to provide advice on and support for regulatory compliance. Projects must demonstrate a thorough understanding of the EU's medical device regulations:
  • Regulation (EU) 2017/745 on medical devices (MDR).
  • Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
  • Projects are expected to help device developers achieve CE marking for their products.
• IP Policy: Standard EU IPR rules apply as detailed in the Model Grant Agreement. Results are owned by the beneficiaries who generate them. The EU retains a royalty-free, non-exclusive, and irrevocable license to use the results for communication and policy purposes.
• Unique Aspects: The grant has a very specific and niche focus on 'orphan medical devices'. These are devices intended for conditions with a low prevalence, making commercial development challenging. The particular targeting of paediatric patients adds another layer of specificity and requires expertise in this demographic's unique needs.
• Industry-Specific Rules: Beyond the MDR and IVDR, projects must consider guidance from the Medical Device Coordination Group (MDCG), specifically mentioning MDCG 2024-10 on scientific advice procedures from expert panels.