EUDAMED Code Search (EMDN, Critical Warning, …)

Do custom-made devices (CMD) have to be registered in EUDAMED – and what about cases of vigilance? What are custom-made products according to the MDR? Please also read our article…

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UDI Devices Module Live Swissmedic is expanding the national medical device database with a central functionality. The UDI Devices module in swissdamed has been live since 18 August 2025. From…

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Europe IT Consulting Successfully Recertified to ISO 9001:2015 On August 6, 2025, Europe IT Consulting GmbH underwent its surveillance audit conducted by QS Zürich AG. The audit report confirms full…

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The European Commission has released an updated EUDAMED rollout plan (July 2025) – this time with a clear note: the timeline is now “under review”. This indicates that, as part…

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MDCG Publishes Timelines for the Introduction of the Master UDI-DI for Eyewear and Contact Lenses The Medical Device Coordination Group (MDCG) has released its MDCG 2025-7 position paper, setting out…

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Executive Summary Turkey is developing into an important sales market for medical devices with a population of 85 million inhabitants and a growing healthcare economy. Despite economic challenges, the medical…

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What is eMDR? eMDR (Electronic Medical Device Reporting) is the US FDA's electronic reporting system for vigilance cases related to medical devices. This system enables the structured and standardized reporting…

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New Schedules for Unique Device Identification (UDI) in Australia The Australian Therapeutic Goods Administration (TGA) has announced the binding timetables for the implementation of the UDI requirements. The UDI system…

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On April 24, 2025, the European Commission released a new technical update for the EUDAMED test environment (Playground). Version v3.11.0 includes significant enhancements, particularly in the UDI/Devices module. Key Updates…

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The Swissdamed platform continues to take shape – and with it the regulatory obligations for manufacturers and distributors of medical devices in Switzerland and Liechtenstein. A central module is now…

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