--- title: "Neolook extends single-source EU MDR position: Neolook One and Mira smart sensorheads" description: Neolook achieves MDR Class I CE certification for both Neolook One and Neolook Mira under one ISO 13485 QMS – the only CE MDR-certified integrated clinical and family monitoring system from a single provider, validated by three independent competitive evaluations across Europe. image: https://www.neolooksolutions.com/hubfs/Neolook%20Logo%20Large%20FC%201160x263.png --- [Skip to content](https://www.neolooksolutions.com/blog/neolook-single-source-eu-mdr-position-neolook-one-and-neolook-mira#main-content) ![Neolook_logo_RGB_FCMark-1](https://www.neolooksolutions.com/hs-fs/hubfs/Neolook_logo_RGB_FCMark-1.png?width=200&height=152&name=Neolook_logo_RGB_FCMark-1.png "Neolook_logo_RGB_FCMark-1") Neolook Uniting those who care Digital eyes and ears on the child in intensive care. Always. English - [Nederlands](https://www.neolooksolutions.com/nl/blog/neolook-single-source-eu-mdr-position-neolook-one-and-neolook-mira) - [Deutsch](https://www.neolooksolutions.com/de/blog/neolook-single-source-eu-mdr-position-neolook-one-and-neolook-mira) - [English](https://www.neolooksolutions.com/blog/neolook-single-source-eu-mdr-position-neolook-one-and-neolook-mira) [Contact us](https://www.neolooksolutions.com/contact-us?hsLang=en) [Home](https://www.neolooksolutions.com/?hsLang=en) [Products](https://www.neolooksolutions.com/products?hsLang=en) [Plans](https://www.neolooksolutions.com/plans?hsLang=en) [Enquiry](https://www.neolooksolutions.com/enquiry?hsLang=en) [Media](https://www.neolooksolutions.com/media?hsLang=en) [Blog](https://www.neolooksolutions.com/blog) [About Us](https://www.neolooksolutions.com/about-us?hsLang=en) This is a search field with an auto-suggest feature attached. - There are no suggestions because the search field is empty. 9 March 2026 # Neolook extends single-source EU MDR position: Neolook One and Mira smart sensorheads [Marco D'Agata](https://www.neolooksolutions.com/blog/author/marco-dagata) Share: [linkedin-in icon](http://www.linkedin.com/shareArticle?mini=true&url=https://www.neolooksolutions.com/blog/neolook-single-source-eu-mdr-position-neolook-one-and-neolook-mira) [envelope icon](mailto:?body=https://www.neolooksolutions.com/blog/neolook-single-source-eu-mdr-position-neolook-one-and-neolook-mira) Neolook achieved MDR CE for both the Neolook One – its high end smart sensorhead with modular design for academic NICUs – and the Neolook Mira – the more affordable integrated variant  – under a single ISO 13485-structured QMS in 2026, extending the only MDR CE medical grade livestream system available from a single provider across the European Economic Area. The position was validated by the market: in independent competitive evaluations – ranging from acdemic NICU's like UMC Utrecht, UMC Leiden and Policlinico die Milano for the Neolook One, to top clinical hospitals like NWZ Noordwest Alkmaar for the Neolook Mira – selected Neolook over alternatives, with hospital procurement teams explicitly citing the MDR CE position as a deciding factor. No competitor in the EU neonatal monitoring segment offers both clinical bedside monitoring and family connection under one MDR CE umbrella. This capstone closes the Neolook One bedside-to-breakthrough cycle and establishes the dual-certified integrated platform as a structural market access moat across all 27 EU member states. [Venture](https://www.neolooksolutions.com/blog/tag/venture) ## Related posts [![](https://www.neolooksolutions.com/hs-fs/hubfs/Neolook%20Logo%20Large%20FC%201160x263.png?height=200&name=Neolook%20Logo%20Large%20FC%201160x263.png)](https://www.neolooksolutions.com/blog/neolook-s2s-family-receives-ce-marking-under-eu-mdr-2017/745-first-and-single-eu-source-for-nicu-family-monitoring?hsLang=en) [Venture](https://www.neolooksolutions.com/blog/tag/venture) ## [Neolook S2S Family receives CE marking under EU MDR 2017/745 – first and single EU source for NICU family monitoring](https://www.neolooksolutions.com/blog/neolook-s2s-family-receives-ce-marking-under-eu-mdr-2017/745-first-and-single-eu-source-for-nicu-family-monitoring?hsLang=en) [Marco D'Agata](https://www.neolooksolutions.com/blog/author/marco-dagata) 9 August 2024 In August 2024, Neolook received CE certification for S2S Family under EU MDR Regulation (EU)... [Read more](https://www.neolooksolutions.com/blog/neolook-s2s-family-receives-ce-marking-under-eu-mdr-2017/745-first-and-single-eu-source-for-nicu-family-monitoring?hsLang=en) [![](https://www.neolooksolutions.com/hs-fs/hubfs/S2SProfessional.jpg?height=200&name=S2SProfessional.jpg)](https://www.neolooksolutions.com/blog/s2s-professional-ce-marked-the-neolook-platform-is-complete?hsLang=en) [Product News](https://www.neolooksolutions.com/blog/tag/product-news) ## [S2S Professional CE Marked: The Neolook Platform Is Complete](https://www.neolooksolutions.com/blog/s2s-professional-ce-marked-the-neolook-platform-is-complete?hsLang=en) [Marco D'Agata](https://www.neolooksolutions.com/blog/author/marco-dagata) 17 November 2025 [Read more](https://www.neolooksolutions.com/blog/s2s-professional-ce-marked-the-neolook-platform-is-complete?hsLang=en) [![](https://www.neolooksolutions.com/hs-fs/hubfs/Neolook%20Logo%20Large%20FC%201160x263.png?height=200&name=Neolook%20Logo%20Large%20FC%201160x263.png)](https://www.neolooksolutions.com/blog/cedars-sinai-medical-center-invests-in-neolook-solutions-first-us-institutional-investor?hsLang=en) [Venture](https://www.neolooksolutions.com/blog/tag/venture) ## [Cedars-Sinai invests in Neolook – first US institutional investor](https://www.neolooksolutions.com/blog/cedars-sinai-medical-center-invests-in-neolook-solutions-first-us-institutional-investor?hsLang=en) [Marco D'Agata](https://www.neolooksolutions.com/blog/author/marco-dagata) 11 November 2025 Neolook Solutions B.V., the Dutch neonatal digital health company, has secured USD 525.000 from... 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