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Call for proposals to support access to medical devices for cross border health threats (HERA) (CP-g-23-13)
EU4Health programme 2021-2027
Estimated EU contribution per project
Link to the call
Link to the submission
This action is part of the Crisis Preparedness strand related to 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.
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.
A consortium should bring together different associations, organisations and/or institutions that can support medical device advancement through all stages of development: concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialisation.
To accomplish this work, a successful consortium should propose activities targeted to unite individuals, groups, or institutions to provide the following capabilities: knowledge of the clinical needs, business planning, conformity assessment requirements, intellectual property protections and other legal expertise, as well as scientific, engineering, pre-clinical, and clinical capabilities.
Expected effects and impacts
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.
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.
These activities will target medical devices and in vitro diagnostic medical devices that can be relevant for preparedness and response to cross-border health threats. Especially those that have issues to ensure access or continuity on the market and that can create a gap in the treatment, prevention or diagnosis of health threats if market access cannot be ensured. The proposals will indicate how compliance with the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation will be ensured. DG HERA should be included in the governance structures as appropriate.
Regions / countries for funding
Moldova (Moldova), Island (Ísland), Norway (Norge), Ukraine (Україна)
Education and training institution, International organization, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)
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.
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)
Other entities may participate in other consortium roles, such as associated partners, subcontractors, third parties giving in-kind contributions, etc.
In order to develop and deliver the above-mentioned activities, the consortium should demonstrate that the consortium competences (directly or indirectly through readily available expertise, i.e. a pool of experts) comprise:
- expertise on cross-border health treats, with special focus on HERA’s priority threats
- legal and regulatory proficiency in the field of medical devices at EU/national levels
- intellectual property protection expertise
- business plan design and market readiness strategies experience
- pre-clinical and clinical capabilities, including proficiency in laboratory and animal testing, proficiency in clinical evaluation and practical steps for medical devices validation, including clinical trials design, and conformity assessment
- scientific/technical capabilities, including applied engineering and mathematics, prototyping and overall product development
- experience in funding and investment mechanisms at EU and international level, and experience with the EU-funding system, including grant-writing and grant-application, investment products, different EU programmes supporting innovation, and if possible, experience in national research and innovation programmes
This need to be clearly mentioned in the proposal.
Natural persons — Natural persons are NOT eligible (with the exception of self-employed persons, i.e. sole traders, where the company does not have legal personality separate from that of the natural person).
International organisations — International organisations are eligible. The rules on eligible countries do not apply to them.
Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees for the protection of the EU financial interests equivalent to that offered by legal persons.
EU bodies — EU bodies (with the exception of the European Commission Joint Research Centre) can NOT be part of the consortium.
Associations and interest groupings — Entities composed of members may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. Please note that if the action will be implemented by the members, they should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible).
European Reference Networks (ERNs) — These cover networks between healthcare providers and centres of expertise in the Member States to reinforce healthcare cooperation, in particular in the area of rare diseases, in line with the objectives set out in Article 12 of Directive 2011/24.
other eligibility criteria
Proposals under this topic must describe the specific needs of the cross-border health threats medical devices sector and show how the activities of the proposal would contribute towards addressing those needs. They should specify the challenges and bottlenecks that developers face and how the project will support them throughout the different phases of medical devices development.
In particular, the project should present a coherent plan of activities including a geographically balanced approach, which ensures equitable access to the services by developers across the EU (e.g., addressing challenges such as language barriers, diverse regulatory environments, among other).
In the proposal, consortia should lay out a fair methodology for the selection of devices that will receive support based on an open rolling application mechanism by which applications can be submitted at all times without a deadline within the lifespan of the grant. The proposals should also outline draft criteria to ensure that support is provided to the most appropriate products. Conversely, proposals are expected to outline possible challenges in reaching out and recruiting developers to participate in this project, as well as respective mitigations measures. The project should also pilot these processes with several products. The proposal should include a plan for this piloting phase including the number of products that can be expected.
Proposals should detail their unique contribution to the EU medical devices innovation ecosystem, how the project will be promoted within the EU and individual Member States, how consortia intend to use existing networks and strategies to foster networking and collaboration, and potential contribution to support the EU open strategic autonomy in the field of medical devices production.
In order to display the developments of the project, the following mandatory deliverables are foreseen:
- Project workplan and implementation plan.
- Every 3 months, regular reports on challenges faced by developers and options to overcome them
- Every 3 months, regular update on the portfolio of devices requesting support
- Open rolling application mechanism (including process to manage it) and methodology for the selection of products and piloting of activities with several products
- Digital marketing materials of the project
- Sustainability report including lessons learned on results of piloting and testing the project
In order to demonstrate progress throughout the project, the visual identity and website as well as the open rolling application mechanism are expected to be implemented in the first six months of the project.
Information and knowledge sharing is mandatory to adhere to national/regional/European/other legislation; notably, GDPR compliance is required. Proposals should include how confidential, sensitive or protective data will be exchanged and which standards will be complied with regard to the sharing of data, if applicable.
Relevance for EU Macro-Region
EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
between 24 and 36 months
The costs will be reimbursed at the funding rate fixed in the Grant Agreement (60%). You can apply for a higher project funding rate (80%) if your project is of ‘exceptional utility’, i.e. concerns:
- actions where at least 30 % of the budget is allocated to Member States whose GNI per inhabitant is less than 90% of the EU average or
- actions with bodies from at least 14 Member States and where at least four are from Member States whose GNI per inhabitant is less than 90% of the EU average.
Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System (accessible via the Topic page in the Search Funding & Tenders section). Paper submissions are NOT possible. Proposals (including annexes and supporting documents) must be submitted using the forms provided inside the Submission System.
Proposals must be complete and contain all the requested information and all required annexes and supporting documents:
- Application Form Part A — contains administrative information about the participants (future coordinator, beneficiaries and affiliated entities) and the summarised budget for the project (to be filled in directly online)
- Application Form Part B — contains the technical description of the project (to be downloaded from the Portal Submission System, completed and then assembled and re-uploaded)
- mandatory annexes and supporting documents (templates available to be downloaded from the Portal Submission System, completed, assembled and re-uploaded):
- detailed budget table/calculator
- CVs (standard) of core project team
- list of previous projects (key projects for the last 4 years) (template available in Part B)