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Neolook S2S Family receives CE marking under EU MDR 2017/745 – first and single EU source for NICU family monitoring

Written by Marco D'Agata | 9 August 2024

In August 2024, Neolook received CE certification for S2S Family under EU MDR Regulation (EU) 2017/745 – making it the first and single EU source: the only MDR-certified medical grade livestream and datastream application platform for the NICU with pan-European regulatory clearance. As a Class I self-declared medical device, S2S Family is available for deployment across the European Economic Area without additional national regulatory approval. The certification closes a five-year clinical adoption lineage spanning seven sites across four countries – from Fatebenefratelli in Rome (2019) to UMC Utrecht and Leiden UMC. ISO 27001 and NEN 7510 certifications are in active progression; NIS2 compliance readiness is next. S2S Family is the proof that Neolook's bedside-to-breakthrough mechanism produces regulated medical devices – not just clinical projects.