Funding programme

EU4Health is the EU’s funding programme to deliver on EU health policy and respond to the COVID-19 pandemic.

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Call overview

This call aims to increase access to medical devices and in vitro diagnostic devices that are intended to treat, prevent or diagnose in relation to across-border health threat.

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Objectives

This action supports the policy priority to increase patients’ access to medical countermeasures and it implements the EU4Health Programme’s general objective of improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and supporting innovation regarding such products (Article 3, point (c) of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (b) and (c) of Regulation (EU) 2021/522.

This action aims to support consortia that provide a platform of experienced regulatory, business planning, and device development services to help foster and guide the advancement of devices that can be used in case of serious cross-border health threats. This action does not cover orphan medical devices (medical devices for rare diseases), as these are addressed by a specific action within this work programme.

The consortia should facilitate the development, production, and distribution of these devices that can be used in case of serious cross-border health threats by providing services and advice on intellectual property, prototyping, engineering, laboratory and animal testing, grant-writing, and clinical investigation design.

Read more in the call document

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Activities that can be funded

More specifically, the project is expected to foster an innovation ecosystem by:

• promoting capacity building and knowledge sharing including by providing capabilities for promising devices.
• establishing connections between individuals and/or entities (e.g., where there is potential for knowledge sharing, joint development, etc.);
• mentoring projects through the development process;
• realistically assessing the scientific, engineering, pre-clinical and clinical innovation potential of the medical devices and adequately guide projects through the best regulatory pathway;
• supporting in finding funding/investment sources, and assessing market opportunities in order to ensure successful prototyping, development, manufacturing and marketing of promising devices;
• and providing business, legal (including intellectual property) and regulatory (and other necessary) support at the stage of submission for conformity assessment.

Read more in the call document

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Expected impact

This action is expected to result in an increased access to medical devices and in vitro diagnostic devices that are intended to treat, prevent or diagnose in relation to a cross-border health threat. The knowledge and information gathered through this action will also provide information on market gaps and recommendations on potential investments in the field of medical devices or in vitro diagnostic medical devices.

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Type of applicants targeted

Scientific societies, academia, health authorities/institutions and NGOs, possibly also including SMEs active and with expertise in the area of the action.

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Consortium composition

Proposals must be submitted by a consortium of at least 3 applicants (beneficiaries; not affiliated entities), which complies with the following conditions: minimum 3 entities from 3 different eligible countries.

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Eligibility

In order to be eligible, the applicants (beneficiaries and affiliated entities) must:

+ be legal entities (public or private bodies)

+ be established in one of the eligible countries, i.e.:

• EU Member States (including overseas countries and territories (OCTs))
• eligible non-EU countries: listed EEA countries and countries associated to the EU4Health Programme or countries which are in ongoing negotiations for an association agreement and where the agreement enters into force before grant signature (list of participating countries)

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Funding available

EUR 1.750.000

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Duration

Expected duration of the project(s) in months: 24-36 months