Woippy, July 16, 2026 – ABL Diagnostics (Euronext Paris: ABLD), a leader in molecular diagnostics for infectious diseases, announced a major milestone in its transition to the European IVDR (EU) 2017/746. In coordination with its parent company, the legal manufacturer of its CE-IVD products, ABL Diagnostics has formally engaged with BSI as its Notified Body, ensuring full alignment with regulatory timelines for its entire portfolio of molecular assays and software medical devices.
The company has successfully met all key preliminary requirements, including an upgraded ISO 13485-certified Quality Management System and timely IVDR submissions. Its Class C products, including DeepChek® assays and software, remain on track for transition by 2028, while Class B UltraGene® qPCR assays will transition by 2029.
To support this process, ABL Diagnostics has strengthened its Governance, Risk & Compliance (GRC) and R&D teams, reinforcing regulatory expertise while accelerating the development of new IVDR-native products. The enhanced quality framework also positions the company for international expansion by supporting compliance with the U.S. FDA Quality Management System Regulation (QMSR) and other global regulatory requirements.
ABL Diagnostics reaffirmed its commitment to ensuring uninterrupted availability of its CE-IVD portfolio throughout the IVDR transition while continuing to develop next-generation molecular diagnostics for customers worldwide.
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