Objective
iNAMed aims to establish a precedent for integrating in silico New Approach Methodologies (NAMs) into the conformity assessment of medical devices under MDR (EU 2017/745). Although AI-driven computational toxicology has reached high scientific maturity, its regulatory uptake remains limited due to insufficient validation, lack of structured benchmarking and absence of formal integration pathways. The project addresses this gap by transforming validated in silico NAMs into a regulator-ready methodology and demonstrating it through a real industrial reference case – the GlucoSet continuous glucose monitoring sensor for ICU patients.
The project builds on the nQTb prototype forming the core of the QL Materials platform (TRL 4), which predicts genotoxicity (Comet assay), mutagenicity (Micronucleus test) and pro-inflammatory responses (IL-6, TNF-α) for nanoforms of TiO2 and SiO2 in line with OECD QSAR Assessment Framework principles.
Stage 1 advances the system to TRL 5 through structured external validation, benchmarking against ISO 10993-relevant endpoints and formal demonstration of methodological equivalence with accepted testing standards. A regulatory integration framework and roadmap for acceptance will be developed, mapping MDR requirements and defining documentation standards aligned with conformity assessment practice. Stage 2 foresees operational deployment within the GlucoSet development workflow, integrating in silico outputs into technical documentation and progressing toward TRL 7.
By reducing early-stage experimental burden, shortening material optimisation cycles and enhancing human relevance through validation on human-relevant models, iNAMed establishes the foundations for scalable, regulatory-grade digital safety assessment. In the longer term, it creates a building block for digital safety twins capable of simulating material–host interactions before clinical exposure, positioning Europe at the forefront of digital regulatory science.
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.
- engineering and technology electrical engineering, electronic engineering, information engineering electronic engineering sensors
- medical and health sciences medical biotechnology tissue engineering artificial pancreas continuous glucose monitors
- medical and health sciences basic medicine pharmacology and pharmacy drug resistance multidrug resistance
- medical and health sciences basic medicine toxicology
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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.3.1 - The European Innovation Council (EIC)
MAIN PROGRAMME
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HORIZON.3.1.3 - Additional EIC activities
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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-EIC - HORIZON EIC Grants
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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-EIC-2026-AIC
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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.
80-244 GDANSK
Poland
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.