Recently, Zybio successfully obtained the EU Quality Management System Certificate (IVDR) issued by TüV SüD, covering our products in Clinical Chemistry, CLIA, Hematology, etc.

The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market, detailing the requirements which manufacturers have to meet.

The IVDR differs in several important ways from the EU's previous directive on in vitro diagnostic medical devices, including re-classification of devices, identification of 'a person responsible for regulatory compliance', implementation of unique device identification, more stringent requirements regarding technical documentation and clinical evidence, among others. Quality, safety and reliability of IVDs will be improved by the IVDR.

A number of products have passed the IVDR CE certification, which marks Zybio scaling a new height in establishing the quality management system, and holds great significance in Zybio's internationalization journey.