Scarlet is a Dutch notified body specialising in AI and standalone software medical devices, designated under Regulation (EU) 2017/745. We strongly support the objectives of this reform to improve the predictability and speed of the conformity assessment process, and welcome the Commission's efforts to better adapt the MDR framework to the realities of software and AI.
Scarlet NB B.V.
Company · Netherlands
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Their record over time
Scarlet NB B.V. filed 2 positions between 6 Oct 2025 and 3 Aug 2026, across 1 of the 692 legislative files tracked here, attaching a full position paper 2 times.
What they argued
Targeted Revision of EU Rules for Medical Devices Scarlet NB B.V. Company Number: 82077177 NB Number: 3022 Keizersgracht 555, 1017 DR Amsterdam, The Netherlands 6 October 2025 Dear DG SANTE – Unit.D3 (Medical Devices) Introduction Thank you for the opportunity to provide feedback on the reform of Regulation (EU) 2017/745.
Opening of the attached position paper · the full paper is on the Commission’s record (source link above)
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