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Join date: Sep 20, 2023
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Nov 12, 2025 ∙ 1 min
Current List of Harmonized Standards under the EU-IVDR (In Vitro Diagnostic Devices)
This overview presents the currently harmonized and relevant standards for in vitro diagnostic devices (IVDs) under the European Regulation (EU) 2017/746 (IVDR). Harmonized standards bridge the gap between legal requirements and technical implementation. They help demonstrate the state of the art and simplify the process of proving conformity with the IVDR. All official Publications of EU-IVDR Harmonized Standards for invitro diagnostic devices (IVDs) Current Status: 09.10.2024 09/10/2024...
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Sep 12, 2025 ∙ 1 min
A Guide Through MedTech Regulation for Startups and Student Innovators
Termin: Wednesday, November 5th, 2025
Winterthur, Switzerland
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Apr 22, 2025 ∙ 2 min
EU MDR 2017/745: FAQ
EU MDR 2017/745 is a regulation of the European Union concerning medical devices. It repeals Directive 93/42/EEC on medical devices...
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Arlette Schilter
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