Regulatory Language Requirements and the European Union

Sustaining competitive advantage within the medical device industry involves a global product strategy that recognizes the European market's substantial global market share. Estimated at 30% of the global medical device market, the European community poses increasing regulatory challenges for medical device manufacturers. Regulations controlling the manufacturing, marketing and usage of medical devices in the EU are forcing manufacturers to incorporate language translation and localization into global development strategies as individual Member States demand product information in the language of the local user.