Seo Beom-seok, CEO of Lunit (left), and Shin Gai Teruo, President of BSI APAC, are posing for a commemorative photo holding the European MDR CE certificate at the 'European Certification Award Ceremony' held at Lunit headquarters in Gangnam-gu, Seoul. (Photo by Lunit)
[Asia Economy Reporter Chunhee Lee] Medical AI company Lunit announced on the 21st that its AI image analysis solution product line, 'Lunit Insight,' has obtained CE certification under the new European Medical Device Regulation (MDR). Along with this, it also acquired the UKCA (UK Conformity Assessed) certification in the UK, which operates a separate certification system after Brexit.
The products that obtained MDR CE and UKCA certification this time are the chest X-ray image analysis solution 'Lunit Insight CXR' and the mammography image analysis solution 'Lunit Insight MMG.' This is the first time an Asia-Pacific (APAC) software medical device (SaMD) company has received these certifications.
MDR, announced in 2017, is a strengthened regulation compared to the previous Medical Device Directive (MDD). MDR legally enforces stricter requirements than MDD regarding product safety, performance, effectiveness, and clinical validation. Not only the product performance itself but also the quality audit standards for manufacturing facilities are stringent.
MDR CE and UKCA certifications have become mandatory for market sales as the European Union (EU) and the UK plan to apply MDR and UKCA certifications from May and June 2024, respectively. Products already on sale will be prohibited from being sold if they do not obtain certification by the application deadline. Previously, Lunit Insight CXR obtained European CE certification in 2019, and Lunit Insight MMG in 2020.
Seobeom Seok, CEO of Lunit, said, "Obtaining MDR CE and UKCA certification clearly demonstrates Lunit's product capabilities and regulatory compliance." He added, "Through this certification, we will proactively respond to sales in the European market and accelerate efforts to expand market share." Shingai Teruo, APAC President of the British Standards Institution (BSI), the UK's national standards body and a global international certification organization, said, "We sincerely congratulate Lunit, the first APAC SaMD company to obtain MDR CE and UKCA certification," and added, "Having established international standards, we hope they will lead the European market."
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