On the 12th, Osang Healthcare, a company specializing in In Vitro Diagnostics (IVD), announced that it had obtained European In Vitro Diagnostic Medical Devices Regulation (IVDR) certification for its personal blood glucose meters.

Osang Healthcare obtained this certification from BSI, a European certification body, and the CE IVDR certification award ceremony was held at Osang Healthcare's headquarters on the 11th. The award ceremony was attended by Hong Seung-eok, CEO of Osang Healthcare, and Lim Sung-hwan, CEO of BSI Korea.

The European CE IVDR certification is a new in vitro diagnostic medical device regulation that was legislated in 2022, raising the performance and safety standards of the existing In Vitro Diagnostic Medical Devices Directive (IVDD). It is an essential certification for entering the European in vitro diagnostic medical device market. This certification is directly applicable to European Union member states and requires transparency in IVD through strict requirements for documentation and clinical evidence, as well as strengthened post-certification reviews by certification bodies.

Full article : Osang Healthcare obtains CE IVDR certification for personal blood glucose meters