新增33證！熱景生物歐盟IVDR CE認證累計獲批78個(gè)產(chǎn)品，國際化進(jìn)程再提速！
2025-02-13
近期，北京熱景生物自主研發(fā)的 33 個(gè)產(chǎn)品通過(guò)歐盟 IVDR CE 認證。這份CE IVDR認證由歐洲最具權威的認證機構之一——英國標準協(xié)會(huì )（BSI）授予。截至2025年2月6日，熱景生物78個(gè)產(chǎn)品已累計獲得歐盟 IVDR CE 認證。
此次獲批的產(chǎn)品涵蓋了熱景生物旗下化學(xué)發(fā)光、上轉發(fā)光、膠體金等主流產(chǎn)品，為進(jìn)一步拓展海外市場(chǎng)奠定堅實(shí)的基礎，彰顯了熱景與國際高水平標準接軌的不懈追求。
CE認證是歐盟市場(chǎng)對于產(chǎn)品準入的強制性要求，視為產(chǎn)品進(jìn)入歐洲市場(chǎng)的“簽證”。2022年，歐盟全面實(shí)施體外診斷醫療器械法規EU 2017/746（IVDR），新法規對體外診斷生產(chǎn)企業(yè)在技術(shù)文檔審查、臨床評估、上市后監管等方面提出了更嚴格的要求。同時(shí)，也表明歐盟各成員國在醫療器械監管的尺度進(jìn)一步統一。
未來(lái)，熱景生物將繼續秉持創(chuàng )新驅動(dòng)的發(fā)展理念，加大研發(fā)投入，推出更多高質(zhì)量的診斷產(chǎn)品，為全球醫療健康事業(yè)的發(fā)展貢獻力量。
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.
