Preparing an EU MDR 2017/745 Submission

Preparing an EU MDR Submission The European Union (EU) Medical Device Regulation (MDR) 2017/745 is an important regulation that affects all medical device manufacturers who want to market their products in the EU. Preparing an EU MDR 2017/745 Submission requires a thorough understanding of the requirements outlined in the regulation. This guide will provide an…

The EU MDR 2017/745

Table of Contents The European Union Medical Device Regulation (EU MDR) is a major piece of legislation coming into force in Europe. It represents a major overhaul of the existing regulatory framework for medical devices and will have significant implications for manufacturers, healthcare providers, and consumers. The new regulation is intended to enhance patient safety…