Bioneer said its real-time PCR quantitative hepatitis B (HBV) and hepatitis C (HCV) assays have received CE-IVDR Class D certification under the EU In Vitro Diagnostic Regulation, the highest-risk category for IVDs. The certification covers use of the assays with Bioneer’s fully automated ExiStation FA 96 system at university hospitals and large reference labs across Europe. The assays use freeze-dried PCR reagents that can be shipped and stored at room temperature, enabling testing in lower-infrastructure settings. Bioneer said it will now work toward World Health Organization (WHO) prequalification, aiming for access through public procurement markets in low- and middle-income countries. The update follows Bioneer’s earlier CE-IVDR Class D certification for a quantitative HIV-1 assay on the same ExiStation FA 96 platform, extending its compliance and commercialization strategy across Europe’s high-stakes infectious disease diagnostics.