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Understanding European Language Requirements for Medical Devices and Pharmaceuticals

european language requirementsUnderstanding 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.

Comments

  1. Paul MacPherson says

    December 12, 2013 at 2:01 pm

    How does one get a copy of the handy guide of which languages are required on various packaging levels by country?

    Thanks in advance,
    Paul

    Reply
    • Roger says

      December 26, 2013 at 5:20 pm

      Hi Paul…

      Very simple. Go to our download page, enter in the required information and check off the publications you would like to download. The download page is located at this link: http://exceltranslations.com/medical-translation/industry-reports/industry-reports-free-download/

      Reply

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