What is Eudamed & How Does it Work?
EUDAMED is a new European system for medical devices that aims to put all aspects of registering, monitoring, and managing information about products among different industry actors. This blog explains what the background to the system is, what it looks like (as far as we know, at the moment) and how it will work. EUDAMED background EUDAMED is the IT system developed by the European Commission to implement provisions of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. Commission published Implementing Regulation (EU) 2021/2078 on 26th November 2021 laying down rules for the application…