EUDAMED Status
EUDAMED Status What do Draft, Discarded, Submitted, and Registered mean for UDI data? Anyone maintaining UDI data in EUDAMED or transmitting it via XML/M2M will regularly encounter different dataset statuses.…
All posts by Ugur Müldür
EUDAMED, swissdamed & AusUDID 2026
2026 increases the pressure to act for manufacturers 2026 will be operationally demanding for many MedTech companies. In the EU, the first four EUDAMED modules will become mandatory from 28…
Global Submission Portal: now TGA Australia / AusUDID as well
Australia in the GSP: Capture UDI data in a structured way, validate it, and centrally manage it for the AusUDID workflow The Global Submission Portal continues to grow: following its…
New MDCG Guidance on the Master UDI-DI
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: Recap
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
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
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
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…