GATE-U

GATE-U Limited is a Hong Kong-based regulatory consultancy helping medical device and IVD manufacturers from Hong Kong, Shenzhen, and the Greater Bay Area access the European Union market. We are the local sister company of MDRC s.r.o. (Slovakia), a European consultancy with 10+ years of experience and over 100 successful CE-marking projects across EU MDR and IVDR. Our services include: - EU Authorized Representative (EC-REP) services - CE-marking strategy and Notified Body coordination - Development of MDR/IVDR-compliant technical documentation - EU AI Act compliance support - ISO 13485 implementation support and post-market compliance - Regulatory training for client teams - Local EU entity setup Based in Hong Kong but backed by a European regulatory team. Our mission is to make EU market entry fast, smooth, and cost-effective for Asia’s MedTech innovators. www.gateu.hk info@gateu.hk