Find EU-funding for your projects now!Search for FundingSearch for programsReset all filters

  1. Select the type of organisation that you are interested in to implement projects.

    The role of an organisation involved could by lead partner, regular project partner, associate partner, and observers.

    Info
    Type of organisation

  2. Select countries that you are interested in to implement projects.

    The funding regions are defined by countries only. In case only part of a country (certain NUTS regions) is eligible for funding relevant information is provided in the description of the programme.

    Info
    Funding region

  3. Select themes that you are interested in to implement projects.

    16 different thematic keywords were predefined when the database was set up. Each call is classified according to this system either with one, two or more themes to facilitate the search for suitable calls.

    Info
    Topics

  4. You can use free text when searching for interesting calls. All you need to do is to enter a phrase in the text bar that EuroAccess is to look for in its database.

    When looking for a phrase in the free text bar, the system will perform an exact-match search. This means that it will search the database for the exact words, in their exact order. However, you can opt for two different approaches:

    1. You can use “AND”, in this way: One AND Two. EuroAccess will look in the database for the fields which records contain both One and Two, regardless of their order and their position in any sentence.

    2. You can use the “OR”, in this way: One OR Two. In this case, EuroAccess will search the database for fields that contain either the word One or the word Two. It will retrieve all the fields with one of these words or with both.

    However, you should prefer phrases or complex words over simple words in you text searches.

    Info
    Keyword
    Selection of eligible entitiesReset all

  1. An institution, body, office or agency established by or based on the Treaty on European Union and the Treaties establishing the European Communities.

    All education and training facilities for people of different age groups.

    An intergovernmental organization having legal personality under public international law or a specialized agency established by such an international organization. An international organization, the majority of whose members are Member States or Associated Countries and whose main objective is to promote scientific and technological cooperation in Europe, is an International Organization of European Interest.

    A person with legal rights and obligations. Unlike a legal entity, a natural person does not have a legal act (e.g. association, limited liability company, etc.).

    An NPO is an institution or organization which, by virtue of its legal form, is not profit-oriented or which is required by law not to distribute profits to its shareholders or individual members. An NGO is a non-governmental, non-profit organization that does not represent business interests. Pursues a common purpose for the benefit of society.

    A partnership, corporation, person, or agency that is for-profit and not operated by the government.

    Any government or other public administration, including public advisory bodies, at the national, regional or local level.

    A research institution is a legal entity established as a non-profit organization whose main objective is to conduct research or technological development. A college/university is a legal entity recognized by its national education system as a university or college or secondary school. It may be a public or private institution.

    A microenterprise, a small or medium-sized enterprise (business) as defined in EU Recommendation 2003/361. To qualify as an SME for EU funding, an enterprise must meet certain conditions, including (a) fewer than 250 employees and (b) an annual turnover not exceeding EUR 50 million and/or an annual balance sheet total not exceeding EUR 43 million. These ceilings apply only to the figures for individual companies.

    Selection of eligible countriesReset all
    Selection of topicsReset all

  1. Governance, partnership: Projects aimed at increasing the application of multilevel and transnational or cross-border governance, designing and testing appropriate governance structures and mechanisms. Also cooperation between public institutions on any theme.

    Innovation capacity and awareness-raising: Actions that increase a person’s or organisation’s capacity for innovation (not innovation as such), and that establish the capacity to diffuse and apply innovation; projects that stimulate innovation in different areas and innovation capacities; strengthening and empowering of innovation networks.

    Institutional cooperation and cooperation networks: Projects working on the improvement of institutional cross-border co-operation and capacities, on renewing and simplifying administrative management through long term cooperation between institutions (e.g. Euregion), on establishing and sharing regional knowledge and intercultural understanding and cohesion. It also deals with cooperations between universities, health care facilities, schools and sports organisations, as well as with management and capacity building.

    Activities focussing on agricultural products, organic farming, horticulture, as well as forest management and wood products; furthermore the development of the food sector, food chains, organic food production, and seafood products and any topics related to animals and fishing.

    Agriculture and fisheries and forestry: Projects focussing on agricultural products (i.e. fruits, meat, olives, etc.), organic farming, horticulture, as well as forest management and wood products. Also the development of the agro-food sector, food chains, organic food production, and seafood products. Any topics related to animals (i.e. health, management) and fishing (i.e. sustainable fishery, aquaculture).

    Soil and air quality: Projects that deal with any topic against soil and air pollution, except water pollution, for example, reduction of soil and air contamination, pollution-management systems, but also prevention and eradication of soil erosion, new ways of improving air quality (also indoors) and soil/air knowledge in general.

    Climate change and biodiversity projects assisting mitigation and adaption to climate change and environmental impacts of climate change. Development of low carbon technologies and strategies, reduction of CO2 emissions from all sectors. Promotion of biodiversity, new instruments to enhance biodiversity and natural protection.

    Soil and air quality projects that deal with any topic against soil and air pollution, except water pollution, for example, reduction of soil and air contamination, pollution-management systems, but also prevention and eradication of soil erosion, new ways of improving air quality (also indoors) and soil/air knowledge in general.

    Water management projects about management and distribution of drinking water, integrated sustainable water management, monitoring systems for water supply and improving drinking water quality; also water treatment (wastewater), in particular, innovative technologies to improve wastewater, treatments in the purification of industrial and domestic wastewater and water reuse policies. Waterways, lakes and rivers: This deals with any topics on waterways, lakes and rivers, from improving water quality, protecting and developing of ecosystems or sustainable wetland management.

    Activities that protect, promote and enhance cultural and natural heritage, increase the attractiveness through preservation and valorisation of common cultural and natural heritage in a sustainable manner, and improve and develop cultural and natural heritage objects, services and products. Cultural heritage management, art and culture, (maritime) heritage routes, access to cultural and natural heritage. Also all topics on cultural services such as festivals, concerts, art workshops.

    Tourism projects dealing with the promotion of natural assets, and the protection and development of natural heritage, as well as increasing the touristic attractiveness through the better use of natural, cultural and historical heritage. Also projects about improved tourist services/products, development of ecotourism models, tourism development strategies.

    Sustainable management of natural resources projects focussing on the protection, promotion and valorization, and sustainable management and conservation of natural areas (habitats, geo parks, protected areas, etc.). Also projects focussing on preserving and enhancing cultural and natural heritage and landscape, as well as protecting the marine environment.

    Projects on waste management (innovative services and strategies), ecological waste treatment, treatment techniques/systems; waste disposal and recycling (improvement of recycling, innovative recycling technologies, recovery of organic waste, repair & re-use centres and networks); also prevention of pollution and pollution control (ecological and circular economy, marine littering, etc.).

    Labour market and employment: creating employment opportunities and/or optimising jobs, academic (un)employment and job mobility, workforce attraction and improvement of employment conditions for different groups.

    SME and entrepreneurship: strengthening SME capacities, boosting entrepreneurial activities in different sectors and for different groups, supporting social entrepreneurship, creating business support/advisory systems for start-ups/spin-offs/incubators, improving the competitiveness of SMEs, and promoting new business processes.

    Community integration and common identity projects that build identity, create a more cohesive society, promote positive relations through an increased provision of shared spaces and services.

    Demographic change and immigration is about projects tackling major societal challenges like demographic change in different areas and migration, in particular, aging society (active aging, best agers, silver economy strategies) and related new public services (adaptation of key services and infrastructure), social and spatial segregation, and brain drain. Also all topics on migration (policy tools, strategic planning, integration).

    All projects where ICT has a significant role, including tailor-made ICT solutions in different fields, as well as digital innovation hubs, open data, Internet of Things; ICT access and connecting (remote) areas with digital infrastructure and services; services and applications for citizens (e-health, e-government, e-learning, e-inclusion, etc.); services and applications for companies (e-commerce, networking, digital transformation, etc.).

    This is about the mitigation and management of risks and disasters, and the anticipation and response capacity towards the actors regarding specific risks and management of natural disasters, for example, prevention of flood and drought hazards, forest fire, strong weather conditions, etc.. It is also about risk assessment and safety.

    Education and training projects on expanding educational opportunities, reducing barriers in the field of education, improving higher education and lifelong learning, training and labour mobility, educational networks, higher vocational education, common learning programmes.

    Topics on energy management, energy-saving methods, evaluating energy efficiency measurements, energy rehabilitation/efficiency in buildings / public infrastructure, promotion of energy efficiency, cooperation among experienced energy efficiency firms, institutions and local administrations, co-generation.

    Projects focussing on wind, solar, biomass, hydroelectric, geothermal and other renewable energy, increasing the production of sustainable renewable energy and improving research capacities in biomass. Also projects focussing on storage and management of renewable energy, new technologies, sustainable regional bioenergy policies and financial Instruments for investments on renewable energy.

    Social projects concerning people with disabilities and excluded groups; enhancement of the capacity of children, young people, women and elderly; creation of infrastructure to improve access for disabled people, integration of socially vulnerable people; innovate in the care of victims of gender violence, social inclusion of women, etc.

    This deals with the development of health and social services and improved accessibility and efficiency for different groups (elderly, children, etc.). It is also about new healthcare models and medical diagnosis and treatments (dementia, cancer, diabetes, etc.), hospitals, care management, and rare diseases, as well as improving wellbeing and promoting sports.

    Projects about (organised) crime, efficient and secure borders, such as enhancing the effectiveness of the police in the prevention of drug crimes, the development of safety services, or tackling security and organised crime issues.

    Activities related to:

    • Transport and mobility covering all sorts of transport (incl. urban transport) and mobility.
    • Improving transport connections dealing with traffic and/or transport connections, rehabiliation/modernisation, better connectivity, improving accessibility/connections, but also public transport.
    • Multimodal transport and logistics and freight transport focusing on using different means of transport, developing multimodal connections, optimising intermodal transport chains; offering multimodal logistics solutions and providing access to clean, efficient and multimodal transport corridors and hubs; establishing cooperation among logistic centres and developing multimodal mobility strategies.

    Activities related to:

    • urban development, such as planning and design of cities and urban areas, urban renewal, urban-rural links (climate, sustainable mobility, water efficiency, participation, sustainable land use, smart cities, public urban areas, regeneration)
    • regional planning and development, such as the implementation of regional development policies/instruments and programmes, sustainable land use management plans, integrated regional action plans, spatial planning, and marine protected area management.
    • rural and peripheral development, referring to remote, sparsely populated areas, rural community development, and rural economics, in particular access to remote areas and policies for rural areas.
    Keyword search
Apply selection

Filter Search for grants

back to the overview

Deadline expired

The deadline for this call has expired.

Call key data

Developing EU methodological frameworks for clinical/performance evaluation and post-market clinical/performance follow-up of medical devices and in vitro diagnostic medical devices (IVDs)

Call number

HORIZON-HLTH-2024-IND-06-08

deadlines

Opening
26.10.2023

Deadline
11.04.2024 17:00

Funding rate

100 %

Call budget

€ 10,000,000.00

Estimated EU contribution per project

between € 8,000,000.00 and € 10,000,000.00

Link to the call

ec.europa.eu

Link to the submission

ec.europa.eu

Call content

short description

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. Proposals should develop a framework for a life-cycle approach to evidence generation and evaluation of high-risk and innovative medical devices and IVDs.

Call objectives

The Medical Device Regulation (MDR) and in vitro diagnostic medical device Regulation (IVDR) provides a new regulatory framework where reinforcement of clinical/performance evaluation of medical devices and IVDs, and in particular high-risk medical devices, is a key element. The confirmation of conformity with the relevant general safety and performance requirements set out in the MDR and IVDR is based on clinical data and its assessment (clinical/performance evaluation), including the evaluation of the acceptability of the benefit-risk- ratio. Within this new framework, the clinical/performance evaluation should follow a defined and methodologically sound procedure based on the critical evaluation of the relevant scientific literature, a critical evaluation of the results of all available clinical investigations/performance studies, as well as consideration of currently available alternative treatment options for the device under evaluation. Clinical/performance evaluation has to be updated throughout the life cycle of the device. Hence, clinical/performance evaluation can draw on multiple types of data including data from initial clinical investigations/performance studies and data gathered by the manufacturer's post-market surveillance system. To operationalise this new requirement, research is needed to help regulators develop common methodological frameworks (including common specifications) on the clinical evidence needed to demonstrate safety, performance and clinical benefit all along the life cycle of devices taking into account the type of device and clinical intended purpose.

Such methodological frameworks and standardised approaches are particularly needed for high-risk medical devices, e.g. implantable and class III medical devices, class C and D IVDs, medical device software (including AI enabled devices and next generation sequencing) and other highly innovative devices.

In order to address the differences between evidence generation for medical devices and IVDs, the project should be tackled taking into account those differences.

Proposals should address all of the following activities:

  • Development of a framework for a life-cycle approach to evidence generation and evaluation of high-risk and innovative medical devices and IVDs. This framework will provide a description of the types of evidence i) that meet safety and performance for market access, and ii) that have to be generated to fulfil post-market responsibilities. When appropriate it would be beneficial to consider to what extent the framework could be relevant to demonstrate relative effectiveness as needed for Health Technology Assessment. As regards highly innovative devices, particular attention may be paid to defining acceptable levels of uncertainty in terms of benefit-risk ratio at market entry as well as the type of post-market follow-up to be implemented to generate additional clinical evidence able to reduce this uncertainty. This could be particularly relevant for devices e.g. having no or little similarities with existing devices in terms of intended purpose, mode of action, materials or, for IVDs, with no existing reference materials.;
  • For medical devices, a pilot to support development of common specifications which would set the stage for a common specification ecosystem for medical devices in the EU, including the development of standardised/common endpoints and associated health outcomes measures by technology type and where relevant by clinical intended purpose;
  • Development of a general methodological approach to define, determine and update the state of the art for different device technologies. The robustness of the developed approach should be evaluated on 3 different medical device types and 3 different IVD types;
  • Possible use of registries and other sources of real-world data for demonstration of regulatory compliance both pre- and post-market: minimum requirements for data quality, completeness and data reliability, statistical methods for data analysis, methods for limiting biases, methods for data linkage, determination of what acceptable evidence can be drawn from registries;
  • Methodology for bridging studies for devices and IVDs with iterative development: assessment of data coming from previous versions of the device and where relevant integration of that data into the device’s clinical investigation/performance study and gap assessment between the different versions of the device;
  • Identification of relevant quantitative and qualitative methodologies for integrating evidence derived from various data sources in the clinical evaluation/performance evaluation;

Proposals should build on relevant completed and ongoing initiatives in the field, in particular (but not restricted to) EU-funded initiatives. Proposals should involve researchers who are specialised in the clinical/performance evaluation of medical devices/IVDs and in the use of real-world data to evaluate medical products. Proposals should involve national competent authorities, notified bodies, IVD laboratories as well as Health Technology Assessment bodies and could involve patients’ representatives where relevant.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

read more

Expected results

Proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all of the following expected outcomes:

  • Patients gain faster access to innovative, safe and well-performing medical devices;
  • Regulators have access to sound scientific resources for clinical/performance evaluation guidance and development of common specifications as foreseen in Article 9 of the Medical Device Regulation (MDR);
  • Notified bodies, by their direct participation to the production of documents, will have a harmonised way of assessing the clinical evidence in the pre-market and post-market phases; furthermore their network, will be enhanced;
  • Health technology developers gain insight on the evidence needed to demonstrate that their devices meet MDR clinical requirements throughout their lifetime. They will also have more guidance on the use of real-world data for their clinical development strategies.

read more

Eligibility Criteria

Regions / countries for funding

EU Member States, Overseas Countries and Territories (OCT)
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Azerbaijan (Azərbaycan), Belarus (Беларусь), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), New Zealand (Aotearoa), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom

eligible entities

Education and training institution, International organization, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)

Mandatory partnership

Yes

Project Partnership

To be eligible for funding, applicants must be established in one of the following countries:

  • the Member States of the European Union, including their outermost regions
  • the Overseas Countries and Territories (OCTs) linked to the Member States
  • third countries associated to Horizon Europe - see list of particpating countries

Only legal entities forming a consortium are eligible to participate in actions provided that the consortium includes, as beneficiaries, three legal entities independent from each other and each established in a different country as follows:

  • at least one independent legal entity established in a Member State; and
  • at least two other independent legal entities, each established in different Member States or Associated Countries.

Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.

A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.

Specific cases:

  • Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
  • Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
  • 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 to protect the EU’s financial interests equivalent to those offered by legal persons.
  • EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
  • Joint Research Centre (‘JRC’)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
  • Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.

other eligibility criteria

In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.

Additional information

Topics

Digitalisation, Digital Society, ICT, 
Health, Social Services, Sports

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)

Additional Information

All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.

Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.

The application form will have two parts:

  • Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
  • Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.

Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).

The limit for a full application (Part B) is 45 pages.

The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

Call documents

HE-Work Programme 2023-2024, Cluster 1, Destination 6HE-Work Programme 2023-2024, Cluster 1, Destination 6(452kB)

Contact

National Contact Points for Horizon Europe
Website

To see more information about this call, you can register for free here
or log in with an existing account.
Log in Register now

back to the overview