New MDCG Guideline 2024-14 Rev.1
What Contact Lens Manufacturers Need to Know About the Master UDI-DI At the end of August 2025, the Medical Device Coordination Group (MDCG) published its revised guidance MDCG 2024-14 Rev.1.…
News
Can a BUDI be “empty”?
Basic UDI-DI in transition scenarios: Can a BUDI be "empty"? 1. Can a Basic UDI-DI (transitional) exist without associated UDI-DI(s)? No – in EUDAMED, a basic UDI-DI is not registered…
€1 Billion for AI
EU Launches "Apply AI": €1 Billion for AI in Key Industries – Focus on Healthcare The European Commission is launching "Apply AI", an investment package worth €1 billion, to accelerate…
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…
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…