EUROPEAN UNION MEDICAL DEVICE REGULATION

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 four years until May 26th 2021 to meet the requirements of this regulation.

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.