新增33证！热景生物欧盟IVDR CE认证累计获批78个产品，国际化进程再提速！
2025-02-13
近期，北京热景生物自主研发的 33 个产品通过欧盟 IVDR CE 认证。这份CE IVDR认证由欧洲最具权威的认证机构之一——英国标准协会（BSI）授予。截至2025年2月6日，热景生物78个产品已累计获得欧盟 IVDR CE 认证。
此次获批的产品涵盖了热景生物旗下化学发光、上转发光、胶体金等主流产品，为进一步拓展海外市场奠定坚实的基础，彰显了热景与国际高水平标准接轨的不懈追求。
CE认证是欧盟市场对于产品准入的强制性要求，视为产品进入欧洲市场的“签证”。2022年，欧盟全面实施体外诊断医疗器械法规EU 2017/746（IVDR），新法规对体外诊断生产企业在技术文档审查、临床评估、上市后监管等方面提出了更严格的要求。同时，也表明欧盟各成员国在医疗器械监管的尺度进一步统一。
未来，热景生物将继续秉持创新驱动的发展理念，加大研发投入，推出更多高质量的诊断产品，为全球医疗健康事业的发展贡献力量。
33 New Certifications! Hotgen Biotech's EU IVDR CE Certifications Reach a Total of 78 Products, Accelerating Internationalization Progress!
Recently, 33 products independently developed by Beijing Hotgen Biotech have passed the EU IVDR CE certification. This CE IVDR certification was granted by one of Europe's most authoritative certification bodies, the British Standards Institution (BSI). As of February 6, 2025, Hotgen Biotech has accumulated a total of 78 products that have received EU IVDR CE certification.
The newly approved products cover Hotgen's main product lines, including chemiluminescence, up-converting phosphor technology, and colloidal gold, laying a solid foundation for further expansion into overseas markets. This achievement highlights Hotgen's relentless pursuit of aligning with international high standards.
The CE certification is a mandatory requirement for product access in the EU market, serving as a "visa" for products entering the European market. In 2022, the EU fully implemented the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746, IVDR), which imposes stricter requirements on in vitro diagnostic manufacturers in areas such as technical documentation review, clinical evaluation, and post-market surveillance. This also indicates a further harmonization of medical device regulations across EU member states.
Moving forward, Hotgen Biotech will continue to uphold its innovation-driven development philosophy, increase investment in research and development, and launch more high-quality diagnostic products, contributing to the advancement of global healthcare.
