News

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…

Read More

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…

Read More

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…

Read More

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,…

Read More

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…

Read More

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…

Read More

Europe IT Consulting introduces the Global Submission Portal with a focus on FDA eMDR New cloud platform combines eMDR, GUDID and EUDAMED in a single system With the Global Submission…

Read More

Save the date: regularia 2026 – Europe IT Consulting will be there On 3 March 2026, the regularia will take place for the first time at Stadthalle Tuttlingen – the…

Read More

What Contact Lens Manufacturers Need to Know About the Master UDI-DI At the end of August 2025, the Medical Device Coordination Group (MDCG) published its revised guidance MDCG 2024-14 Rev.1.…

Read More

Basic UDI-DI in transition scenarios: Can a BUDI be "empty"? 1. Can a Basic UDI-DI (transitional) exist without associated UDI-DI(s)? No – in EUDAMED, a basic UDI-DI is not registered…

Read More