WHAT IS EU MDR?

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and  distribution of medical devices in Europe. Compliance with this new regulation is mandatory for all medical  device companies that want to sell their products in the European market.

The Medical Device Regulation was officially published on May 5th 2017 and came into force on May 25th 2017. Medical devices  companies like Medtronic have had a transition time of three years until May 26th 2020 to meet the requirements of this regulation.

WHAT DOES THE EU MDR MEAN FOR YOU?

This regulation brings forth a set of new standards and requirements with which our products need to comply. 

  • Updated Product Label
  • New Product designs
  • Detailed Technical Information
  • Clinical Trial data

WHAT CAN YOU EXPECT FROM THE EU MDR?

Some of our products cannot be made MDR compliant which means they will be either phased out or replaced by an appropriate alternative.  

LEARN MORE

Click any of the button below to access more information about MDR or if you would like our local sales representative to provide you a complete overview of the impacted products and the proposed alternatives.