Navigating the Intricacies of EU Medical Device Consulting: Ensuring Compliance

The European Union (EU) medical device market stands as one of the largest and most stringent globally. Manufacturers face the challenge of adhering to complex regulations, notably the EU Medical Devices Regulation (MDR) (2017/745) and the EU In Vitro Diagnostics Regulation (IVDR) (2017/746). This article explores the intricacies of medical device registration in the EU and offers guidance on achieving MDR compliance.