NEW: EU Language Requirements Tool

NEW from Casus: EU Language Requirements Tool

Manufacturers must translate their medical device and IVD labeling into the official language(s) required by the EU member state. This is mandatory so that end users will understand how to correctly use the product.

With 27 national languages throughout Europe, navigating the language requirements can be challenging. Knowing whether the labels and instructions for use (IFU) / user manual (UM) must be translated is confusing and over-translating can result in unnecessary expense.

To help you maintain compliance, Casus has developed a free Language Requirements Tool. Its benefits include:

• Provides the local requirements for the European Single Market, the United Kingdom (UK), and Switzerland
• Outlines the requirements for devices intended for the lay person and for healthcare professionals
• Specifies if a member state allows the IFU/user manual to be provided in English
• Confirms if a national competent authority has published that manufacturers may request a language exemption
• The regulation excerpt and link are included for reference

Click here to review more information related to the language requirements in Europe and to check out our free tool!