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: 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…
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…
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…
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.…
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…
EU Launches "Apply AI": €1 Billion for AI in Key Industries – Focus on Healthcare The European Commission is launching "Apply AI", an investment package worth €1 billion, to accelerate…
The full UDI lifecycle – everything from a single source The path to full UDI compliance can be understood as a data cycle: UDI master data → Traceability → Vigilance…
When does the UDI-DI status need to be changed?In EUDAMED, the status (not the country end data) decides whether a device is considered "On the EU market" or "No longer…
Do custom-made devices (CMD) have to be registered in EUDAMED – and what about cases of vigilance? What are custom-made products according to the MDR? Please also read our article…