DNV supports NOUL in IVDR certification for AI-based medical diagnostic products

14 January, Seoul, Korea - DNV, the independent global assurance and risk management provider, is partnering with Korean AI-driven blood and cancer diagnostics company 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.

 

-END-

About DNV

DNV is a trusted Notified Body for medical device certification under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). We provide independent, rigorous, and transparent assessments to ensure that medical devices placed on the market are safe, effective, and reliable throughout their lifecycle.

Our role goes beyond compliance, we partner with manufacturers to navigate complex regulatory requirements, balancing innovation with patient safety and quality. With deep technical expertise and global reach, DNV supports customers in achieving market access, maintaining regulatory integrity, and building trust in their products.

Driven by our purpose to safeguard life, property, and the environment, we help advance patient safety and healthcare outcomes while enabling manufacturers to thrive in a rapidly evolving regulatory landscape.

Learn more at https://www.dnv.com/medical-devices/

 

About Noul Co., Ltd.

“Enabling blood and cancer diagnostics anywhere in the world with AI.”

Founded in December 2015, Noul (376930.KQ) is an on-device AI healthcare company with a mission to explore global challenges that threaten human health and life, discover novel solutions, and realize those possibilities. Noul has commercialized the world’s first AI-powered diagnostic lab, miLab™, through convergence of AI, biotechnology, and compact robotics.

The miLab™ is the only solution that fully automates the microscopic diagnostic process—from sample preparation to AI-based image analysis—delivering lab-grade blood and cancer diagnostics at the point of care. Within 15 minutes, miLab™ produces precise results even in low-resource settings.

In 2022, miLab™ was described in a UNITAID report as “The most advanced digital microscope and fully integrated bench-top platform” for malaria diagnostics. It is now deployed in 28 countries, used by pharmaceutical companies, hospitals, labs, and public health institutions worldwide.

With strong clinical validation and proven performance, Noul is rapidly expanding its market presence, especially in malaria, blood analysis, and cervical cancer diagnostics. The company’s vision is to make a meaningful impact on the lives of 1 billion people worldwide through accessible, innovative diagnostic technologies.

Website: https://noul.com