Translating In Silico NAMs into Regulatory Practice for Medical Devices

Ziel

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.