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…
Our Excel templates are now available for purchaseOur proven Excel templates are available for purchase in an optimised and user-friendly design. The templates for preparing, collecting and managing your UDI…
The unique device identification initiative for medical devices and in vitro diagnostic medical devices is now an international hot topic and how you, as a manufacturer, respond will affect your…
What is MDR/IVDRLegislationThe new European Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/ 746) replace the existing medical device directives.Since 25.05.2017, the EU regulations, the…
If you are a medical device manufacturer who have to meet the UDI requirements of the european union (EUDAMED) then is this video a must for you.Please enjoy our video. …
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct MarkingFinal guidance from the US Food and Drug Administration pushes back enforcement…