On December 17, 2019, the final vote for the second corrigendum to the Medical Devices Regulation (2017/745, MDR) took place. It is now officially confirmed that some class I medical… Read More
Second MDR corrigendum published
Category: MDR
Technical Documentation Requirements under the MDR – a Case Study
You may already have asked yourself how Regulation (EU) 2017/745 on medical devices (MDR) affects the Technical Documentation requirements for your products. This is a very complex question and cannot be… Read More
Notified Body Selection and Change
Notified Bodies have a crucial role in the CE Marking process. Below you will find an overview of the role of Notified Bodies and what is important when selecting and changing… Read More