Bioneer said its real-time quantitative hepatitis B and hepatitis C PCR assays received CE-IVDR Class D certification in Europe for use with the company’s ExiStation FA 96 fully automated system. Bioneer said the certification is its highest-risk category under the EU In Vitro Diagnostic Regulation and covers the assays run on the high-throughput platform. The company said it will expand sales of the HBV and HCV tests to university hospitals and large reference laboratories across Europe. It is also pursuing World Health Organization prequalification with a logistics advantage: the assays use freeze-dried PCR reagents that can be transported at room temperature for settings with limited infrastructure. Bioneer noted that it previously secured CE-IVDR Class D certification for a quantitative HIV-1 assay on the same instrument platform, building a broader viral diagnostics footprint. The move positions Bioneer to compete in procurement-driven regions where stable, low-resource transport requirements can be decisive. Regulatory acceptance at Class D under CE-IVDR can materially accelerate adoption timelines and expand commercial addressability for automated molecular diagnostics.