Compared to other European countries, many German economic operators have not yet been assigned their Single Registration Number (SRN), and there are reasons for this. The Federal Ministry of Health…
You may have noticed that the UDI rules are quite complex and involve different actors. If you are in the MedTech industry, it is even more important to be clear…
Handlungsbedarf für Medizinproduktehersteller im Bereich UDI GUDID / EUDAMED Was für Lebensmittel heute bereits gilt, wird auch für Medizinprodukte Realität. Die Rückverfolgbarkeit muss sichergestellt werden, mit dem übergeordneten Ziel, die…
https://www.youtube.com/watch?v=5-3xiXmfjhg&feature=youtu.beLearn in this short video how our global UDI software solution helps you ensure a smooth and successful UDI implementation.
The first MedTech manufacturers have already got their SRN. If you want to find out which companies they are, please have a look on the following link: https://ec.europa.eu/tools/eudamed/#/screen/search-eo
We released the EUDAMED SAP Add-On Version V2020/12. This Version contains many improvements like:Data handlingTranslations to ENPerformance optimizationsUDI Excel Template UpdateFor more details read the UDI Add-On EU Release Notes…
Find out here about the latest UDI Implementation Timeline for EUDAMED.
https://www.youtube.com/watch?v=vuK0Fj55x-U&feature=youtu.beWhat is UDI? What are the goals? Who is affected? How can UDI be successfully implemented?Learn all important information about Unique Device Identification for EUDAMED and FDA in this short…
Despite Corona, the Swiss Medtech Day 2020 was able to take place in Bern in compliance with safety arrangements. Europe IT Consulting GmbH was also part of the event and…