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…
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…
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…
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…
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…
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…
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…
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…
The introduction of the Medical Device Regulation brought about a significant change: the assignment of Unique Device Identifiers (UDIs) for medical devices.This step has been taken to improve the identification,…
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…