ntroduction to EU4Health

The EU4Health Programme (2021-2027) is the European Union's response to the lessons learned from the COVID-19 pandemic and long-term health challenges. With a budget of €5.3 billion, it is the EU's largest health programme ever, aiming to strengthen health systems, improve crisis preparedness, ensure access to medicines and medical devices, and promote innovation for better healthcare. EU4Health funds actions that support disease prevention, health promotion, and access to high-quality, safe, and affordable healthcare for all EU citizens.

Call Summary: Orphan Medical Devices Programme (focus on paediatrics)

Expected Impact

• Promote the development of innovative orphan medical devices, particularly addressing unmet medical needs in paediatric patients.

Objective

• Support innovation in medical devices through non-profit organisations or consortia that bring together academia, scientific societies, SMEs, NGOs, and other relevant stakeholders.

• Foster and guide the development of orphan devices for areas where medical solutions are lacking, with a strong paediatric focus.

Scope & Eligible Activities
Funding may cover a broad range of activities across the full development pipeline, including:

• Intellectual property advice, prototyping, engineering, testing (lab/animal), grant-writing, and clinical investigation design.

• Mapping unmet medical needs and encouraging innovation by connecting academia, societies, users, and manufacturers.

• Mentoring projects through product identification, prototype design, device development, and market preparation.

• Linking developers and clinicians to financing resources.

• Assessing scientific/medical merit of proposed devices.

• Supporting pre-clinical data generation to ensure safety and performance.

• Providing advice on business development, training, IP protection, and post-marketing needs.

• Guiding regulatory pathways and supporting CE marking compliance under Regulations (EU) 2017/745 and 2017/746, including MDCG 2024-10 guidance and expert panel advice.

Eligibility Criteria and Requirements

1. Eligible Entities

• Non-profit organisations, associations, and consortia.

• Academic institutions, scientific societies, NGOs with an interest in innovative medical devices.

• SMEs developing devices may participate, typically as consortium members.

• Research institutes, hospitals, and clinical centres can join if they bring relevant expertise.

2. Consortium Composition

• Proposals must usually come from a consortium (not from a single applicant, unless explicitly allowed).

• The consortium should bring together independent entities from different sectors (academia, SMEs, clinical experts, users, regulators).

• Participation from different EU Member States or associated countries is encouraged to ensure a European dimension.

3. Geographic Scope

• Applicants must be legally established in an EU Member State or an EU4Health associated country.

• Activities must be carried out in the EU/associated countries or provide clear EU-wide benefits.

• Entities from restricted countries (e.g. Russia, Belarus, non-controlled territories in Ukraine) are not eligible.

4. Project Scope

• Projects must focus on the development, design, production, distribution, or support of orphan medical devices, especially addressing unmet paediatric needs.

• Activities may cover the full development pipeline: prototyping, pre-clinical testing, IP advisory, clinical study design, regulatory guidance, market preparation.

5. Budget and Duration

• EU contribution: up to €250,000 per project.

• Duration: typically 1-3 years.

• Eligible costs include R&D, testing, regulatory and business advisory services, training, and dissemination, provided they meet EU financial rules.

6. Regulatory Compliance

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