On July 18th in Cologne, Germany, the Ministry of SMEs and Startups (MSS) of Korea signed a memorandum of understanding with TÜV Rheinland to support Korean small and medium-sized enterprises, including those from the Gangwon AI Healthcare Global Innovation District, in entering the European AI medical device market. AI medical devices are cutting-edge products capable of predicting diseases and providing personalized treatments by learning autonomously from extensive medical data and integrating this into healthcare services.

However, the pace of technological change in AI-based products is rapid, and they can continue to evolve through learning even after being released into the market. In contrast, medical devices undergo a stringent certification process that permits only minor post-certification modifications, presenting significant market entry barriers for smaller enterprises with limited access to certification expertise and testing facilities.

TÜV Rheinland, a European CE certification body, has recently bolstered its capabilities by establishing an AI Lab in Berlin and leading the development of European standards for AI medical devices. Collaborating with TÜV Rheinland is anticipated to be highly beneficial for entering the European market, which is increasingly regulating the AI medical device sector.

MSS and TÜV Rheinland will collaboratively identify promising companies and support them through the rigorous and lengthy certification process of medical devices, from the product development stage to performance verification and comprehensive testing. Additionally, to ensure robust validation of AI medical devices, Korean SMEs and German universities will collaborate to jointly assess the safety and efficacy of these devices.

Lim Jung-wook, Director of the Venture Innovation Office at MSS, stated, “Our partnership with TÜV Rheinland, a global leader in medical device certification, will significantly aid Korean AI medical device startups in entering the European market. This year, although we plan to support ten companies from the Gangwon AI Healthcare Global Innovation District, we aim to expand our support by integrating various commercialization initiatives of MSS.”

Furthermore, Director Lim discussed policy directions for fostering AI startups and explored potential collaboration opportunities, including participation in DeepL‘s ComeUP event, with the CEO of DeepL, a renowned global AI translation unicorn.