SIGMA has been Certified with Medical Devices Regulation (MDR) of the European Union

Delighted to announce that SIGMA has been approved as per the Medical Device Regulation (MDR) of the European Union. The MDR became applicable in the EU from May 26, 2021 and regulates medical devices that sell in the region.  

Medical devices must undergo a conformity assessment to demonstrate they meet legal requirements, are safe, and perform as intended. The aim of MDR is to ensure the proper functioning of the medical device market in the EU while providing a high level of protection for patients and users. 

Being compliant with the EU's MDR further elevates SIGMA's alignment with the strictest global standards that offer uncompromising protection.