The MDR workshop took place yesterday. Anja Wiersma from Mi-ce was the speaker who informed the participants about the impact of the new MDR for medical devices. She led us through the major and relevant changes on regulations for medical devices and IVD Products.
Topics like MDR timelines and Changes to classification were covered. And at the request of the attendees Anja got into depth on the following three topics: Clinical evaluation process: (What is enough data? How to gather the data?), Post Market Surveillance process (including PMS plan, PSURs, PMCF) and Eudamed/UDI.
It was a very diverse group of participants, from app developers to suppliers and manufacturers of medical devices. As all participants have to deal with these changes in their organisation and how they each have to be compliant in their own way with the new MDR regulations. We thank Anja for this very informative session!
If you were unable to attend, you can view the workshop with a great deal of practical information about the new MDR here.