Domestic AI Medical Devices Set to Establish Footing for Entry into Europe

Collaboration with Global Certification Body 'TUV Rheinland'
Supporting AI Healthcare Companies in Obtaining Global Certification

A foothold is being established for domestic artificial intelligence (AI)-based healthcare companies' medical devices to enter the European market.

On the 18th, the Ministry of SMEs and Startups announced that it signed a business agreement with 'T?V Rheinland' in Cologne, Germany, to support the entry of domestic SMEs into the European market in the AI medical device sector.

AI medical devices are innovative products that independently learn from vast medical data and utilize it in healthcare services, enabling disease prediction and personalized treatment. However, while AI-based products rapidly evolve with technological changes and can continuously adapt through learning even after market launch, medical devices require lengthy certification processes and only allow very limited changes after certification. This has made timely market entry difficult for SMEs lacking certification experts and testing equipment.

Lim Jeong-wook, Director of the Startup Venture Innovation Office at the Ministry of SMEs and Startups, is taking a commemorative photo with Simo Dekishi, Vice President of the Global Medical Devices Division at T?V Rheinland, after the 'Ministry of SMEs and Startups-T?V Rheinland Business Agreement Ceremony' held in Germany on the 18th (local time).

T?V Rheinland is one of Europe's leading certification bodies and recently established an AI lab in Berlin to strengthen its AI medical device certification capabilities. It is also leading the development of European AI medical device standards. This collaboration is expected to greatly assist market entry into Europe, where regulations on AI medical devices are being tightened.

The Ministry of SMEs and Startups and T?V Rheinland will support domestic SMEs in AI medical device product development stages, including performance verification and comprehensive testing and inspection, by providing technical advice and preliminary technical reviews. In particular, to drastically resolve the difficulties caused by the lengthy medical device certification process, promising companies will be jointly selected to support expedited certification.

Additionally, to ensure sufficient demonstration of AI medical devices, joint verification of safety and efficacy will be conducted based on industry-academic cooperation among domestic SMEs and local German universities. Exchange and cooperation between experts from both countries will also be promoted to secure the reliability of AI medical devices and respond to EU regulations.

Lim Jeong-wook, Director of the Startup Venture Innovation Office at the Ministry of SMEs and Startups, said, “Cooperation with T?V Rheinland, a world-class medical device certification body, will greatly help domestic AI medical device startups enter the European market,” adding, “This year, we plan to select and support 10 companies in the Gangwon AI Healthcare Global Innovation Zone. We will expand the support targets by linking with various commercialization support projects of the Ministry of SMEs and Startups.”