What makes e-labeling translations so important in the medical devices industry? With new frontiers in med device markets emerging globally, instructions for use (IFUs) are a requirement in most markets, which makes e-labeling translations for IFUs a necessary investment for medical device vendors. International medical device sales require IFUs to detail usage instructions and device-specific safety messages, which must be approved by regulators before the device is brought to market. In the shift to a more automated and digitized regulatory landscape, US and EU markets further require IFUs in an e-label format, which means that vendors need to provide translated versions of the IFU e-label during the submission process. To meet regulatory standards and help ensure the safety of end users, medical device companies needing assistance with e-labeling translations for IFUs should work with a trusted language service provider (LSP) who can provide high-quality e-labeling localization solutions combined with the language coverage to meet your IFU translation needs.
Why e-Labeling Translations for IFUs Are Necessary in Medical Device Sales
While companies largely need e-labeling translations for compliance purposes and the digital format tends to lessen the volume of hard copy documents, there are additional added benefits for stakeholders involved in bringing new products to market. For instance, e-label translations are necessary because not all end users of the device will speak the same language and companies seeking to grow their business overseas can efficiently improve visibility and protect the end user by reaching people in their native language. Moreover, e-labeling translations are stored digitally, which means new IFUs can easily be developed and updated to different countries’ safety requirements or developed into new languages entirely. With strict regulations in place and added benefits for stakeholders when it comes to e-labeling translations, LSPs can leverage several important and effective localization solutions for delivering consistent and cost-effective translations of IFU e-labels.
e-Labeling Translations for IFUs: How it Works
Like other life science localization solutions, e-labeling translations involve subject matter experts who are well-versed in global medical regulations as well as linguists who have the language expertise and resources to format e-labels for different countries’ markets. For example, many LSPs in the life sciences are familiar with the 24 languages required by EU’s Medical Device Regulation (EU-MDR 2017/745) for IFUs and providing translation services in this space allows the linguists to better understand the timelines and turnaround times it takes to deliver projects on time. Formatting e-labels to accommodate the layout of different languages and the necessary safety markings is another important aspect of e-labeling localization and is done so with solutions like desktop publishing (DTP) and developing glossaries to hold the translated words and phrases that will be included on the IFU. Regardless of the target market and language, e-labeling translations can be carried out with expert localization solutions.
With a global network of 10,000+ linguists and life science subject matter experts, CSOFT Health Sciences has the proven experience to deliver e-labeling translations that help companies swiftly and effectively reach new global markets. Visit lifesciences.csoftintl.com to learn more about our e-labeling translations for IFUs.