Is Back Translation Right for You?
3 min read
In part one of this series, we looked at the overarching differences between the European Union’s Medical Device Regulation (MDR) and the United States’ Food and Drug Administration (FDA). This time out, we’re going to pinpoint the critical differences in unique device identification (UDI) requirements.
At its most basic, UDI is a system used to mark and identify medical devices within a healthcare supply chain. At present, the International Medical Device Regulator Forum (IMDRF), the FDA, and the European Commission are hammering out details for a globally consistent approach to UDI that will increase patient safety and help optimize patient care by setting up global standards. Let’s examine the key differences in existing approaches to see how they might be brought together under one roof.
The US FDA released, in September 2013 a rule which establishes that a unique device identifier number should be assigned by the device manufacturer to each version or model of a device, and that the unique device identifier should be both in human readable format and in AutoID format. In addition:
The EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) were adopted in 2017 and define the requirements for the EU’s UDI system. One new concept that has been introduced by the EU regulations is the basic UDI-DI, which allows for the grouping of regulated medical devices within EUDAMED, the EU regulatory database for regulated medical devices. Some other stipulations include:
In a global marketplace, labels are naturally expected to be multilingual. However, new UDI formatting requirements reduce the size of external labeling space and make it harder to include multiple languages or use languages that take up more space. At Argos Multilingual, our translation, localization, and desktop publishing (DTP) specialists are ready to help your organization meet global requirements and best serve your customers. Click here to find out more!
Get in touch
We are committed to giving you freedom of choice while providing subject matter expertise and customized strategies to fit your business needs.Contact us