BiomateSWISS will continue to certify and comply with the EU Medical Device Regulation Quality Management System


BiomateSWISS will continue to certify and comply with the EU Medical Device Regulation (MDR) Quality Management System




BiomateSWISS always insists on offering products and services of the highest quality in the market and will persist in maintaining such standards.


To regulate medical device manufacturers more effectively and ensure consumer safety, the European Union (EU) officially implemented the EU Medical Device Regulation (MDR) on May 26, 2021, replacing the EU Medical Device Directives (MDD). Numerous new requirements have been introduced, building upon the original MDD.

BiomateSWISS will continue to certify and comply with the MDR, aiming to provide high-quality protection for patients' health and dentists' usage.