Dynamiker Obtains CE IVDR Certification for Six Fungal & AMR IVD Assays

Six self-developed in vitro diagnostic assays of Dynamiker Biotechnology have been granted CE IVDR certification by global notified body TÜV Rheinland. These kits are designed for detection of invasive fungal diseases and carbapenem-resistant bacteria.

EU IVDR enforces far stricter IVD regulatory standards than the obsolete IVDD directive, with rigorous rules for quality management, clinical validation, risk control and post-market monitoring. The successful certification of these six individual products validates Dynamiker’s independent R&D capabilities and internationally compliant quality control system.

This milestone reinforces our global competitiveness and underpins our market expansion across Europe and other international regions. The IVDR-certified product suite fulfills global clinical needs for rapid, accurate identification of invasive fungi and multidrug-resistant pathogens.

Going forward, Dynamiker will continue developing and registering more diagnostic products to meet overseas clinical and regulatory demands, delivering trustworthy testing tools for global infectious disease prevention and treatment.