MedTech consultant and Practice Manager with over 40 years of experience in the medical device industry.
Medical device and In-Vitro Diagnostics product safety and regulatory expert with extensive experience of regulatory and product safety requirements across the product lifecycle.
After an extended deadline, EU MDR has replaced the Medical Devices Directive (MDD) in May 2021. As the binding legislative act for all MedTech developers on the EU market, MDR raises the bar in several areas (including clinical evidence, technical documentation, post-market surveillance, and the responsibilities of economic operators such as distributors and importers).
All of this has significant implications for the way in which manufacturers develop new products, test them, place them on the EU market and monitor their performance thereafter. In this guide, independent MedTech experts Howard Broadbridge and James Pink cover what this change means for MedTech developers and how they can best tackle compliance with the new regulations!
Download this guide for an overview of key changes in EU MDR vs MDD, an analysis of how MDR affects the various departments and disciplines of a MedTech organization, and best practices on updating your product development process and Quality Systems in order to ensure compliance!