Understanding European language requirements for medical devices and pharmaceuticals is crucial as countries within Europe have specific translation requirements for computer software, Instructions for Use (IFU), packaging, and other Medical Device and Pharmaceutical labeling. In this ever-changing regulatory and international market clearance environment, it is vitally important for you to have this information at your fingertips. Without it you are unable to proactively properly plan your international market clearance strategy. In addition to the language requirements there are trends and country-specific requirements for the medical device directives and pharmaceutical regulations.
A comprehensive, easy-to-understand matrix is available to help you understand the necessary European Language requirements for both Medical Devices and Pharmaceuticals. This helpful guide outlines the medical device and IVD language requirements, pharmaceutical language requirements, national requirements in addition to the device directives, and additional requirements and exceptions for pharmaceuticals.