Objective
DIGICAP aims to advance the harmonisation and digitalisation of conformity assessment procedures (CAP) under the EU MDR and IVDR. The associations Team-NB and MedTech Europe representing the majority of European notified bodies (NBs) and medtech manufacturers (MFs) respectively, have joined forces to address the urgent challenges arising from the complexity of CAP, which makes the time and cost of certification difficult to predict. DIGICAP builds on their existing CAP harmonisation and digitalisation initiatives and their ability to reach consensus positions within their sectors, to make a real world impact in this issue.
Representatives of the NBs and MFs, including SMEs, will collaborate with experts in data-driven digitalisation as well as legal, regulatory and public health experts, to deliver an Open Source DIGICAP framework with structured machine-readable data and standardised exchange formats. Under the technical coordination of a research institute experienced on digitalisation of regulatory processes, this project ensures a vendor-neutral approach, fostering innovation and fair market opportunities.
The project takes an open and inclusive approach, actively involving additional representatives of all the main stakeholder groups including regtech enterprises, through a stakeholder engagement programme. These representatives will co-design a consensus-based DIGICAP framework aligned with real-world stakeholder needs. NBs and MFs will conduct pilots to provide early proof of concept for the efficiency, completeness and usability improvements that the proposed digitalisation will deliver. The results of these pilots will inform the design of a feasible yet ambitious roadmap for the future implementation of DIGICAP across the EU. The roadmap will define the steps needed to reduce the complexity and burden of MDR and IVDR certification through digitalisation, ensuring that European MFs, particularly SMEs, can maintain their competitive edge.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences health sciences public health
- medical and health sciences basic medicine pharmacology and pharmacy drug resistance multidrug resistance
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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.2.1.6 - Health Care Systems
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HORIZON.2.1.5 - Tools, Technologies and Digital Solutions for Health and Care, including personalised medicine
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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-CSA - HORIZON Coordination and Support 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-HLTH-2025-01
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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.
4140 Sprimont
Belgium
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Participants (18)
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1066EP AMSTERDAM
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20123 Milano Mi
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1322 Hovik
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115 28 Athens
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75015 PARIS
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3041 Limassol
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
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.
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D09 A0E4 DUBLIN 9
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1010 Wien
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1000 Ljubljana
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60325 Frankfurt Am Main
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80339 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.
1000 BRUSSELS
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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.
501 15 Boras
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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.
1019 HC Amsterdam
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2400 Mol
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91058 Erlangen
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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.
28050 MADRID
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
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.
3513 CR Utrecht
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
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.