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Meridian Bioscience Achieves IVDR Certification for Alethia® Molecular Assay Portfolio
CINCINNATI, February 24, 2026--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.
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[{"type":"text","content":"CINCINNATI, February 24, 2026--(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.","length":344,"tagName":"p"},{"type":"text","content":"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:","length":220,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Alethia Pertussis and Alethia Pertussis External Controls","length":57,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Alethia GBS and Alethia GBS External Controls","length":45,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Alethia CMV and Alethia CMV External Controls","length":45,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Alethia Malaria and Alethia Malaria External Controls","length":53,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Alethia Chlamydia","length":17,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Alethia Gonorrhea","length":17,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Alethia HSV 1&2 and Alethia HSV 1&2 External Controls","length":61,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":295,"olType":false},{"type":"text","content":"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.","length":413,"tagName":"p"},{"type":"text","content":""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-compl...