regularia 2026: Recap
regularia 2026: Recap – Exchange on MDR, Digitalization & UDI On Tuesday, March 2nd, 2026, we were present at regularia 2026 – with our booth in the entrance area. The…
All posts by Ugur Müldür
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…
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…
Seasonal Greetings
Merry Christmas and a great start to 2026! An intense year is drawing to a close – with many projects around UDI, EUDAMED, FDA GUDID & more. Together with you,…
Press Release – UDI Excel Cloud Validator on SAP Store
UDI Excel Cloud Validator from Europe IT Consulting GmbH Now Available on SAP® Store By integrating with SAP Business Technology Platform, the UDI Excel Cloud Validator from Europe IT Consulting…
EUDAMED to Become Mandatory from 28 May 2026
EUDAMED: Four Modules Mandatory from 28 May 2026 With the publication of a new Commission Implementing Decision in the Official Journal of the European Union on 27 November 2025, the…