Neolook Solutions obtained CE marking for S2S Professional in 2025 under Regulation (EU) 2017/745, producing the CE Certificate, Declaration of Conformity and Clinical Evaluation Report summary as a Class I self-declared device under Article 52(7). The certification closes the bedside-to-breakthrough cycle for the S2S Professional lineage: a clinical problem identified inside European NICUs, a solution co-developed with hospital partners, deployed across Dutch academic medical centres, and now formally certified for unrestricted deployment across all 27 EU member states. EU MDR 2017/745 CE marking requires a complete Technical File, ISO 13485-certified QMS, and a clinical evidence base built through genuine clinical partnerships – a pathway competitors cannot replicate retroactively. S2S Professional becomes Neolook's second CE-certified product and the regulatory reference point for an expanding portfolio; EarlyMoves and Cry Detection CE pathways are active.