Global Translation Requirements for Medical Devices

Labeling, IFU and translation may seem like minor issues compared to larger registration efforts, but the accuracy of the information supplied with your medical device is essential to avoid costly mistakes and market entry delays.

Questions? Request more information from our specialists


Companies exporting their devices to international markets often underestimate the importance of translations. You may have an excellent product and a top distributor, but if your translations of device labels and IFU are poor, it can hurt sales and damage the reputation of your company. And, poor translations pose a liability risk if a misunderstanding leads to misuse of your device by a patient or user.

In this article, we'll answer your biggest questions about requirements and best practices for translating device labeling and Instructions for Use (IFU). You will learn:

  • What do European regulations and others say about translations?
  • Is it possible to be exempt from translation requirements?
  • What are the risks of not translating our materials?
  • When to go above and beyond the minimum translation requirements?
  • What should we consider when hiring a translation company?

You will learn all this and more in this 8-page white paper.

About the Author

Chris Schorre: Chris Schorre is Vice President of Global Marketing at Emergo and has 25+ years of experience in B2B marketing and strategy. He previously held senior marketing positions at Farmers Insurance, Zurich, and several B2B ad agencies.