EUDAMED explained clearly
EUDAMED explained clearly: Packaging hierarchy vs. Unit of Use DI (and what “Base Quantity” really is) In EUDAMED, three topics are very often confused: packaging hierarchy (container packages), Unit of…
Archives 2026
swissdamed Updates: EMDN-Codes and Legacy Devices
swissdamed Updates: EMDN Codes and Legacy Devices Swissmedic has published two key swissdamed releases: With version 2.2.1, swissdamed supports the current EUDAMED schema (XSD 3.0.25 / platform 2.22.0), including updated…
EUDAMED UDI Registration
Mastering EUDAMED UDI Registration – Where to Start & How to Overcome Uncertainties? For many manufacturers, registering medical devices in the European database EUDAMED feels like a mammoth project: new…
GSP: MIR Reporting (EUDAMED Vigilance)
Global Submission Portal: Now including MIR Reporting (EUDAMED Vigilance) Finally: Capture, validate, and submit EU Manufacturer Incident Reports centrally – in a single workflow. The Global Submission Portal is taking…
regularia trade fair on March 3, 2026 in Tuttlingen – Meet us there!
regularia 2026 on March 3rd in the Tuttlingen town hall Program is online – meet Europe IT Consulting at Booth 12 On March 3, 2026, regularia – the new regulatory…