新增33證！熱景生物歐盟IVDR CE認(rèn)證累計獲批78個產(chǎn)品，國際化進程再提速！
2025-02-13
近期，北京熱景生物自主研發(fā)的 33 個產(chǎn)品通過歐盟 IVDR CE 認(rèn)證。這份CE IVDR認(rèn)證由歐洲最具權(quán)威的認(rèn)證機構(gòu)之一——英國標(biāo)準(zhǔn)協(xié)會（BSI）授予。截至2025年2月6日，熱景生物78個產(chǎn)品已累計獲得歐盟 IVDR CE 認(rèn)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(zhuǎn)發(fā)光、膠體金等主流產(chǎn)品，為進一步拓展海外市場奠定堅實的基礎(chǔ)，彰顯了熱景與國際高水平標(biāo)準(zhǔn)接軌的不懈追求。
CE認(rèn)證是歐盟市場對于產(chǎn)品準(zhǔn)入的強制性要求，視為產(chǎn)品進入歐洲市場的“簽證”。2022年，歐盟全面實施體外診斷醫(yī)療器械法規(guī)EU 2017/746（IVDR），新法規(guī)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(jiān)管等方面提出了更嚴(yán)格的要求。同時，也表明歐盟各成員國在醫(yī)療器械監(jiān)管的尺度進一步統(tǒng)一。
未來，熱景生物將繼續(xù)秉持創(chuàng)新驅(qū)動的發(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(yī)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.
