Fidelma Conway

The UDI Requirements of the New EU MDR – What You Need to Know

by Fidelma Conway
The new EU MDR (Medical Device Regulation) changes several aspects of obtaining and then maintaining regulatory approval for medical devices. One of the major changes is the introduction of an identification system, or UDI, for medical devices approved for use in the EU. While the implementation of the new EU MDR has been delayed because of COVID-19, everyone in the industry is impacted by this change in UDI requirements. This includes those with products that have been on the market for years, to companies and start-ups developing new medical devices that have yet to go through the approval process. Introduction...