YHLO Receives First IVDR Class D CE Certification
We are thrilled to announce that YHLO has successfully obtained its first IVDR Class D CE certification for our HBeAg diagnostic product in the field of liver disease. This certification, awarded by the British Standards Institution (BSI), marks a significant milestone, reaffirming the technical prowess and product quality of YHLO in the chemiluminescence domain.
The CE certification is a vital passport for products entering the European Union (EU) market, ensuring they meet the stringent safety, performance, and quality standards as mandated by EU regulations. On May 5, 2017, the EU introduced the In Vitro Diagnostic Regulation (IVDR) (Regulation (EU) 2017/746) to safeguard public health by categorizing products based on risk levels, ranging from Class A (lowest risk) to Class D (highest risk), each subject to varying levels of regulatory oversight.
Viral hepatitis, a widespread infectious disease caused by various hepatitis viruses, remains a significant global public health challenge. According to the latest data from the World Health Organization, the global prevalence of HBsAg is approximately 3.8%, with 296 million people living with chronic hepatitis B in 2019. Hepatitis B products are regarded as high-risk by regulatory bodies worldwide, necessitating rigorous clinical evaluations and complex review processes by notified bodies. The achievement of the IVDR Class D CE certification for our HBeAg diagnostic product highlights YHLO's capability to provide high-quality, competitive diagnostic solutions to international clients, demonstrating our commitment to contributing to global healthcare.
During the IVDR certification award ceremony, YHLO's team engaged in in-depth discussions with the BSI team on enhancing certification efficiency and exploring further collaboration opportunities.
As a leader in the in vitro diagnostics industry, YHLO remains dedicated to innovation and quality, continuously striving to improve healthcare services through advanced products and solutions. The acquisition of our first IVDR Class D CE certification is not only a prestigious honor but also a significant responsibility. Moving forward, we will remain steadfast in our mission to address clinical needs, working closely with BSI and other professional organizations and global partners to advance the development of high-quality healthcare worldwide.
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