Implantica AG (publ) announced that it has received Medical Device Regulation (MDR) certification from its Notified Body, BSI, for the company and RefluxStop?. The latest Notified Body survey published by the European Commission in July 2023 estimated that of 11,418 MDR applications, only 2,951 had successfully achieved MDR certificates. Implantica is in the top quartile of manufacturers achieving MDR certification for its products.
Implantica was granted the EU Quality Management System (QMS) certificate and the EU Technical Documentation Assessment Certificate confirming Implantica's QMS and the RefluxStop? are compliant with the latest regulations and standards required for medical devices in Europe.