Archives 2026

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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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