2025-05-21
Recently, Hangzhou Biotest Biotech has obtained EU CE IVDR certification for 54 new products. The certification was issued by TÜV SÜD, an EU-recognized Notified Body, under the IVDR regulation. This marks another breakthrough following the company’s first batch of IVDR-certified products in June 2023. To date, Biotest Biotech has secured IVDR certification for a total of 126 products, covering multiple application areas, including drug abuse testing, infectious disease testing, women’s health testing, tumor marker testing, and inflammation indicator testing. The issuance of these new certificates further solidifies Biotest Biotech’s leading position in the global rapid diagnostics industry for EU IVDR-certified products.
As a global leader in rapid drug testing, Biotest Biotech has always been at the forefront of technological advancement and regulatory compliance. This certification makes Biotest Biotech the world’s first manufacturer to successfully obtain IVDR certification for Multi-Drug Rapid Tests. The certified drug testing kits cover both urine and saliva samples, offering diverse product formats and rich combinations to meet testing needs across various scenarios. Currently, Biotest Biotech has become one of the few manufacturers globally with a comprehensive portfolio of EU IVDR-certified drug abuse testing products, providing customers worldwide with more complete and reliable diagnostic solutions.
The EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746), a major upgrade to the EU regulatory framework, officially came into effect on May 25, 2017, systematically replacing the nearly two-decade-old In Vitro Diagnostic Medical Devices Directive (IVDD, 98/79/EC). The regulation, fully implemented starting May 26, 2022, introduces stricter clinical evidence requirements, enhanced lifecycle supervision, and a traceability system, establishing the world’s most stringent regulatory framework for in vitro diagnostics to improve patient safety and diagnostic reliability.
As an innovator in the IVD field, Biotest Biotech adheres to a development philosophy driven by innovation and grounded in quality, having established a full-process quality management system compliant with IVDR standards. The company is now accelerating IVDR certification for a broader range of products, including POCT devices and supporting reagents for professional healthcare institutions, as well as rapid self-testing solutions for home use. Backed by a well-structured technical documentation system audited by EU Notified Bodies and supported by cutting-edge R&D platforms, Biotest Biotech is advancing from traditional immunochromatographic testing to microfluidic precision diagnostics.
We firmly believe that consistently verifiable quality is the foundation for competing in the global market, extensive IVDR registration experience is a key differentiator in building competitive barriers, and the growing global demand for precise and convenient diagnostic solutions is the core driver of technological innovation. Biotest Biotech will continue leveraging regulatory advancements as an opportunity to deepen its "Quality+" strategic layout, delivering superior diagnostic value to customers worldwide.
Please fill in your contact information
and your needs
