Meridian Bioscience Achieves IVDR Certification for Alethia® Molecular Assay Portfolio

Original from: business wire

Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced that a broad portfolio of its Alethia molecular assays has successfully achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.

The certification, issued by GMED (Notified Body 0459), confirms that 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. Achieving IVDR certification underscores Meridian’s commitment to delivering high-quality, compliant diagnostic solutions to laboratories and healthcare providers across Europe.

“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.”

“This achievement reflects Meridian’s unwavering commitment to quality, regulatory excellence and customer continuity,” said Andy Kitzmiller, Chief Executive Officer of Meridian Bioscience. “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.”

The Alethia platform provides rapid, easy-to-use molecular testing designed to streamline workflows and deliver accurate detection of infectious diseases in clinical laboratory settings. With IVDR certification in place, Meridian reinforces its long-term commitment to the European market and to maintaining uninterrupted product availability during the industry-wide regulatory transition.

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.

Source: Meridian Bioscience Achieves IVDR Certification for Alethia® Molecular Assay Portfolio