Navigating the Complexities of EU Medical Device Consulting: How to Ensure Compliance

The European Union (EU) medical device market is one of the largest and most stringent markets globally. To ensure patient safety and product efficacy, manufacturers must navigate complex regulations, particularly the EU Medical Devices Regulation (MDR) (2017/745) and the EU In Vitro Diagnostics Regulation (IVDR) (2017/746). This article delves into the challenges of medical device registration (EU) and provides a roadmap for achieving MDR compliance.