DNV SUPPORTS NOUL IN IVDR CERTIFICATION FOR AI-BASED MEDICAL DIAGNOSIS PRODUCTS

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SEOUL, South Korea, January 14, 2026 /PRNewswire/ — DNV, the independent global insurance and risk management provider, partners with Korean AI company blood and cancer diagnosis Noul to certify its malaria diagnosis, blood cell morphology and cervical cancer testing solutions in accordance with the European Union’s In Vitro Diagnostic Medical Devices (IVDR) Regulation.

The EU IVDR provides a regulatory basis for establishing the safety and effectiveness of new in vitro diagnostic (IVD) devices. Most IVD devices require an IVDR certificate of conformity to receive the CE marking authorizing their sale in the EU. However, many other countries also recognize that CE marking is sufficient to commercialize IVD devices, thus making IVDR compliance a gateway to global market access.

As an IVDR Notified Body, DNV will carry out certification of three Noul solutions: the miLab™ MAL cartridge for malaria diagnosis, the miLab™ BCM cartridge for blood cell analysis and the miLab™ CER cartridge for cervical cancer testing. The solutions are based on Noul’s innovative miLab™ point-of-care diagnostic platform. Combining integrated sample preparation, digital imaging and AI analysis, miLab ensures consistently high-quality testing and efficient workflows in any environment – from cutting-edge urban hospitals to remote rural clinics.

“Noul’s AI-powered diagnostic laboratory, miLab™, combines accuracy and efficiency, and healthcare organizations around the world are interested in how miLab can help them provide better care.

“The world needs innovative diagnostic solutions like Noul’s miLab, which must be brought to market with confidence in their safety and accuracy while minimizing unnecessary delays. As one of the top 5 Notified Bodies in the world – and thanks to our global team of auditors, technical assessors and clinicians – DNV offers efficient certification with the flexibility to adapt to manufacturers’ timelines and business objectives,” said Cecilie Gudesen Torp, Global Director of Medical Services at DNV.