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Please find below the latest regulatory news in Europe.
The Federal Council of Switzerland also has published on 1. November 2023 the updated IvDO which is related to medical devices in Switzerland.
With Notified Body Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi from Türkiye now 40 NB's are designated according to EU MDR.
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Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. QMSR Tool - 5 days left at intro price (-20%) With the link below, you get direct access to the tool. Offer ends by September 30, 2025. Link to Tool Do you need more detailed information? Check our QMSR Tool guide here: Link to Guide Regulation and Guidelines: (New): COMMISSION DELEGATED REGULATION (EU) 2025/1920 of 12 June 2025 amending Regulation (EU) 2017/745 of the European...
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Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Our new QMSR Gap-Assessment Tool is currently available at a special 20% discount until September 30, 2025. (Prices will increase in October.) Test Tool Regulation and Guidelines: Opinion of the European Committee of the Regions Cybersecurity of hospitals and healthcare providers This document provides policy recommendations on cybersecurity for hospitals and healthcare...