We obtained certification for the first products under the new European Medical Device Regulation MDR (EU) 2017/745

We have great news to share! After years of hard work, we have successfully obtained MDR approval for two of our female urinary incontinence product families: Female Remeex System and Contasure Needleless.

What is the MDR?

The MDR is the new European Regulation on medical devices that defines the requirements and obligations that all manufacturers and distributors must comply with in order to market a medical device in the European market. In addition to incorporating the previous Directives 90/385/EEC and 93/42/EEC, this Regulation establishes stricter requirements and measures in line with the global evolution of the medical device market.