Project description
New framework for early feasibility studies for medical devices
EU regulations mandate a lifecycle approach to generate clinical evidence for medical devices (MD). A comprehensive evidence-generation plan, shaped by stakeholder input, is crucial in early product development. Early feasibility studies (EFS) are part of the pre-market clinical investigations, yet the EU lacks standardised frameworks for EFS. The EU-funded HEU-EFS project seeks to establish a harmonised framework for the EU EFS programme. The initiative involves analysing pre-market MD programmes, devising a widely applicable EU methodology, conducting pilot use-cases, developing tools for EFS performance monitoring and establishing an accessible online portal. The HEU-EFS consortium comprises research organisations, patient organisations, health technology assessment bodies, healthcare providers, SMEs, legal experts and six major private companies.
Objective
EU Regulations on medical devices (MDs), in-vitro diagnostics, and Health Technology Assessment envisage a harmonised lifecycle approach for clinical evidence generation of MDs. To be effective this approach requires evidence generation plan to be developed since early stages of product development, by engaging all relevant stakeholders.
At present, in the EU there are no standardized procedural frameworks/guidelines/common reference standards for Early Feasibility Studies (EFS), clinical investigations allowed by ISO 14155:2020 conducted early in the development aiming to inform the product development.
The ambition of the HEU-EFS project is to develop a harmonised framework for the EU EFS Program, as one integrated step of evidence generation cycle. Project objectives include: (1) conducting research/analysis on state of play (i.e. characteristics, challenges, impacts) of pre-market programs for MDs, including EFS; (2) building a sustainable network of stakeholders at EU/national level to promote/support EFS implementation; (3) developing a sound, widely applicable, harmonised EU methodology and formulating recommendations to uptake EFS; (4) undertaking pilots to test the proposed framework; (5) developing instruments to monitor the EFS performance; and (6) implementing a dedicated, sustainable, open access online portal dedicated to EFS methodological framework, best practices and network.
To achieve these goals, the HEU-EFS consortium has been designed including a wide range of relevant stakeholders: research organisations, HTA bodies, patient organizations, healthcare providers, SMEs (including health technology developers, legal experts, and a CRO), and 6 major private companies that are part of a pre-identified industry consortium. An Advisory Board made of competent authorities, notified bodies, medical and biomedical engineering professional associations, networks and industry trade association will collaborate to the success of the initiative.
Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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HORIZON.2.1.7 - Innovative Health Initiative
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-JU-IHI-2022-02-two-stage
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
20136 Milano
Italy
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Participants (38)
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08036 BARCELONA
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08036 Barcelona
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00187 Roma
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75012 PARIS
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2333 CG Leiden
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00198 Roma
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
0456 Oslo
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D02 CX56 Dublin
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35037 Marburg
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7100 Vejle
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78140 Velizy-Villacoublay
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
00168 Roma
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1000 BRUSSELS
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20121 Milano
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
H91FF68 Galway
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56072 KOBLENZ
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
1702 Dilbeek
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
92614 IRVINE CALIFORNIA
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4818 CL Breda
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
78280 Guyancourt
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
85748 GARCHING B. MUNCHEN
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
1260 NYON
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
6229GW Maastricht
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
01600 Trevoux
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37135 Verona
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5013 CE Tilburg
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5684 PC BEST
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1831 Machelen
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SL6 4XE Maidenhead
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
1930 Zaventem
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
94593 RUNGIS CEDEX
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2132 JD Hoofddorp
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19801 WILMINGTON
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2610-008 AMADORA
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65205 Wiesbaden
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19801 Carlsbad
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19801 Wilmington
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4436 Oberdorf Bl
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