Guide

Enhancing Transparency and Safety in Medical Devices

The European Union's introduction of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) marks a significant shift towards enhanced transparency in the medical device sector.

While these regulations are designed to strengthen patient safety following several high-profile device failures, they have also created complex labeling updates and post market reporting requirements.

Medical device companies must now navigate these complexities through strategic use of technology and robust documentation and translation practices to align with these stringent new standards.