On June 23, 2016, the United Kingdom (UK) voted for the UK to leave the EU, which is commonly referred to as Brexit. Since then, there has been no clear… Read More
What about Brexit?
Month: December 2018
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
Why is a Clinical Evaluation so Important?
Both, the Medical Devices Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 on Medical Devices (MDR) require manufacturers of medical devices to draw up a clinical evaluation for their devices. The overall aim… Read More
Labeling Changes under the Regulation (EU) 2017/745 on medical devices (MDR)
The MDR brings many challenges for medical device manufacturers. Certainly, an area that requires increased attention and careful planning is labeling. Section 23 of annex I of the MDR defines… Read More