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Recently, 234 Autobio products have passed the IVDR CE certification and received the IVDR CE extension certificate issued by TÜV SÜD, the Notified Body of the European Union. After this extension, the number of Autobio IVDR CE certificates has increased to 326, covering immunological, microbiological, molecular and other mainstream products.

CE certification is a mandatory requirement for product access to the EU market and is considered a 'visa' for products to enter the European market. In 2022, the EU will fully implement the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746), which imposes stricter requirements on manufacturers of in vitro diagnostic medical devices in terms of technical documentation review, clinical evaluation, post-market surveillance, etc. The CE certificate is issued by Autobio. supervision and other aspects, the requirements are more stringent. At the same time, it indicates further harmonisation of the level of regulation of medical devices among EU member states.

At Autobio, we place significant emphasis on the attainment of IVDR CE certificates. In 2021, Autobio's Thyroid Function Magnetic Microparticle Chemiluminescence reagent series became the first product in the company's range to be awarded the EU IVDR CE certificate. In 2023, Autobio's Autof MS series, a fully-automated microbial mass spectrometry detection system, and the hepatitis B virus surface antigen (HBs) reagents series were granted the EU IVDR CE certificate. In July and September respectively, the Viral Surface Antigen (HBsAg) Test Kit (Magnetic Microparticle Chemiluminescence) became the first products in China to be awarded EU IVDR CE certificates. Furthermore, Autobio has completed the IVDR CE conversion for its range of testing products for tumour markers, TORCH, thyroid function, reproductive hormones, cardiac muscle, inflammation, bone metabolism, diabetes, hypertension and autoimmunity.

The completion of IVDR CE conversion of Autobio's core product range provides a robust foundation for further expansion in overseas markets.