A broad swath of Meridian Bioscience Inc.’s Alethia molecular assay platform has earned CE mark certification under the European In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.

“This achievement reflects Merdian’s unwavering commitment to quality, regulatory excellence, and customer continuity,” Meridian Bioscience CEO Andy Kitzmiller said. “The transition to IVDR is one of the most demanding regulatory shifts our industry has faced. Successfully certifying our Alethia product demonstrates the strength of our teams and reinforces our long-term dedication to supporting healthcare providers across Europe with reliable, high-performance molecular diagnostics.”

Issued by GMED (Notified Body 0459), the certification confirms the following Alethia assays and associated external controls are compliant with IVDR requirements and are classified as Class C under the regulation:

• Alethia Pertussis and Alethia Pertussis External Controls
• Alethia GBS and Alethia GBS External Controls
• Alethia CMV and Alethia CMV External Controls
• Alethia Malaria and Alethia Malaria External Controls
• Alethia Chlamydia
• Alethia Gonorrhea
• Alethia HSV 1&2 and Alethia HSV 1&2 External Controls

IVDR represents a significant evolution in the European regulatory framework for in-vitro diagnostics, introducing more rigorous requirements for clinical evidence, performance evaluation, quality systems, and post-market surveillance.

“This milestone reflects the strength of our quality systems and the dedication of our regulatory, quality, and product teams,” said Susan Bogar, vice president, Regulatory Affairs, at Meridian Bioscience. “We are proud to continue supporting our European customers with IVDR-compliant molecular diagnostics that deliver reliable, actionable results.”

The Alethia platform provides rapid, easy-to-use molecular testing that streamlines workflows and delivers accurate detection of infectious diseases in clinical laboratory settings. Meridian Bioscience will continue to advance its portfolio in alignment with evolving global regulatory standards while supporting customers through ongoing compliance and market access requirements.

Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes diagnostic testing solutions and life science raw materials. Meridian’s diagnostic products provide accurate, simple, and cost-effective testing solutions to help diagnose and manage gastrointestinal, respiratory, parasitic, and other infectious diseases. The company’s Life Science segment supplies critical raw materials used by researchers and other diagnostic manufacturers worldwide.