UDI Lifecycle
The full UDI lifecycle – everything from a single source The path to full UDI compliance can be understood as a data cycle: UDI master data → Traceability → Vigilance…
Category News
EUDAMED: UDI-DI status change?
When does the UDI-DI status need to be changed?In EUDAMED, the status (not the country end data) decides whether a device is considered "On the EU market" or "No longer…
EUDAMED Clarification: Custom-Made Medical Devices and Vigilance Reporting
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…
swissdamed: Medical Device Registration Now Available
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…
Successful ISO 9001:2015 Recertification
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…
Update: EUDAMED Rollout Timeline Under Review (July 2025)
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…
Timelines for the Introduction of the Master UDI-DI
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…
Medical device sales market in Türkiye: opportunities and challenges
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…
FDA Electronic Medical Device Reporting
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…
Key Dates: UDI Requirements in Australia
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…