New MDCG Guidance on the Master UDI-DI for spectacle frames, spectacle lenses and ready-to-wear reading spectacles published With the document MDCG 2025-8 Rev. 1, the Medical Device Coordination Group published…
regularia 2026: personal conversations, strong market impulses, and valuable insights for digital regulatory practice Once again, regularia 2026 showed how strongly the medical technology industry is operating in the tension…
EUDAMED Data Management: Europe IT Consulting GmbH Uncovers Critical Error Sources in UDI Updates The experts at Europe IT Consulting GmbH have identified a significant vulnerability in the EUDAMED architecture…
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…
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…
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…
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 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…