UDI EUDAMED FAQ
Many economic operators have questions in the course of their UDI implementation, which are also asked by other economic operators. We have summarized and answered the most frequently asked questions…
EUDAMED has been announced as mandatory — sign a contract in 2025 and secure a special discounted price.
News
Single Registration Number (SRN) assignment delayed
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…
UDI Role Overview
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…
Merry Chrismas and a Happy New Year
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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…
Global UDI solution for MedTech companies
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.
Single registration number (SRN) search is available
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
EUDAMED SAP Add-On Update available
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…
UDI Implementation Timeline for EUDAMED
Find out here about the latest UDI Implementation Timeline for EUDAMED.
All information about Unique Device Identification
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…