The European In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) now applies in the world’s second-largest medical device market. The new Regulation introduces major changes to how manufacturers obtain CE Marking and maintain access to the European market.
Make sure you have an actionable roadmap to IVDR compliance with clear decisions and direction. Emergo by UL expert consultants and SaaS tools give you access to world-class global resources to simplify access to European market.
European Authorized Representative for IVD companies
Gap assessment and CE transition strategy for IVD manufacturers
RAMS simplifies Tech Documentation File, Performance Eval Report / Plan