DNV SUPPORTS NOUL IN IVDR CERTIFICATION FOR AI-BASED MEDICAL DIAGNOSTIC PRODUCTS
SEOUL, South Korea, Jan. 14, 2026 /PRNewswire/ -- DNV, the independent global assurance and risk management provider, is partnering with Korean AI-driven blood and cancer diagnosticscompany Noul to certify their malaria diagnosis, blood cell morphology and cervical cancer testing solutions, under the European Union's In Vitro Diagnostic Medical Device Regulation (IVDR).
The EU's IVDR provides a regulatory basis for establishing the safety and effectiveness of new in-vitro diagnostic (IVD) devices. Most IVD devices require a certificate of compliance with the IVDR to receive a CE mark that allows their sale in the EU. However, many other countries also recognize the CE mark as sufficient to market IVD devices, making IVDR compliance a gateway to global market access.
As an IVDR Notified Body, DNV will carry out certification on three Noul solutions: the miLab™ MAL cartridge for malaria diagnosis, miLab™ BCM cartridge for blood cell analysis and 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, the miLab ensures consistently high-quality testing and efficient workflows in any setting – from state-of-the-art urban hospitals to remote rural clinics.
"Noul's AI-powered diagnostic lab, miLab™, combines accuracy and efficiency, and healthcare bodies around the world are interested in how miLab can help them deliver better care. Timely certification against appropriate standards is essential to our global expansion plans. Working with DNV's local team of medical device certification experts here in Korea will help us take a big step in those plans," said Taehwan (TH) Kim, Chief Business Officer and Head of Europe Regional Office at Noul.
"The world needs innovative diagnostic solutions like Noul's miLab to be delivered to market with full confidence in their safety and accuracy while minimizing unnecessary delays. As one of the top 5 notified bodies globally – and thanks to our global team of auditors, technical assessors and clinicians – DNV offers efficient certification with the flexibility to adjust to manufacturers timelines and business goals," said Cecilie Gudesen Torp, Global Director Medical Services at DNV.