Medical device software qualification
Before jumping headfirst into the complexity of the Medical Device Regulation, you must be 100% sure that it is worth it. This assessment can be complex if you sell health-related…
Category Technical article
The long-term benefits of UDI
The process of UDI implementation according to EUDAMED and/or FDA requirements is time-consuming and costly. However, there are significant benefits that go far beyond mere compliance. As a manufacturer and/or…
UDI format for GS1 & HIBC
The format of your UDI codes, Basic UDI-DI and UDI-DI, depends on the selected Issuing Agency. For the two most commonly used Issuing Agencies, GS1 and HIBC, we have summarized…
Summary: Guidance on the Management of Legacy Devices
On the 8th February 2021 the European Commission published a Guidance on the Management of the Legacy Devices. It explains in detail how Legacy Devices will be identified and the…
EUROPE IT EUDAMED Excel Submission method workflow
By using the Europe IT submission method, you can easily submit your UDI data to EUDAMED via Excel. But before starting to consider the data transfer process, make sure you…
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…
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…
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…
MDR / IVDR: Timeline – Changes – Impact
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…