Skip to main content

Get a Head Start on In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) Compliance

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.

clinical study audits

European Authorized Representative for IVD companies

mdr eu authorized

Gap assessment and CE transition strategy for IVD manufacturers

mdr eu post market

RAMS simplifies Tech Documentation File, Performance Eval Report / Plan

Don't put it off. Contact us today to learn how we can help you transition to new IVDR 2017/746.