CE Marking, sometimes referred to as CE Mark or the European Trade Passport, signifies that a product is verified and compliant with consumer and environmental protection standards regarding public health and safety for the European Economic Area (EEA). The term CE Marking stands for “Conformité Européene” in French which translates to European Conformity. The EEA is comprised of the 27 EU member states as well as Iceland, Liechtenstein, and Norway, making CE Marking imperative for any products manufactured, marketed, or produced in a large and extremely diverse market. While CE Marking is not a quality assurance step, it is a mandatory safety marking that demonstrates conformity to directives.
The new EU MDR implementation is causing changes to the translation requirements of CE Markings. Previously, technical documents that required CE marking did not require translation pre-approval. Under the MDR, however, documents that receive CE markings like labelling, instructions for use (IFUs), and patient information documents must be translated into the official languages of each country. Further, countries may designate additional languages required for diverse populations within the country. Accurate translation that is “clear and precise” is necessary across all official languages and is essential in ensuring that regardless of who is reading the material, it is understood entirely and effectively. For companies that fail to comply with CE Marking, it can mean a potential investigation from the local regulatory body, causing delays in the production timeline and ultimately losing revenue.
CSOFT provides highly accurate CE Marking translations for life science companies expanding overseas. With an extensive network of over 10,000 in-country linguists and subject matter experts, we understand the importance of timely and accurate CE mark translations.
Medical Device Translation
CE Marking is a requirement for all medical device products, from in-vitro diagnostic medical devices to active implantable medical devices, in gaining market access and complying with local regulatory requirements. For medical device companies expanding into the EEA market, accurate translation is necessary in gaining CE Marking, particularly under the new MDR.
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High-quality translation is extremely important for CE Marking– inaccurate translation along the way can not only result in wasted time, money, and effort, but also endanger patient safety. That is why CSOFT is dedicated to ensuring the highest-quality translation and interpretation solutions for every step in the development and marketing process for life science companies. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts. In addition, we have perfected our localization best practices through back translation and terminology management to help reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions for the pharmaceutical industry, CSOFT’s proven expertise is backed by our ISO 9001:2015 and ISO 13485:2016 certified quality management system.
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CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are compliant with ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.
Learn more about how CSOFT protects your data.