What Are eIFUs and Why Do They Matter?
As medical device manufacturers shift toward digitization, Electronic Instructions for Use (eIFUs) are becoming the new standard. eIFUs replace traditional paper instructions, providing users with digital access to important device information, such as usage guidelines, safety precautions, and maintenance procedures.
But going digital doesn’t remove the need for accurate translation and localization; it amplifies the critical need for clear, understandable, accessible instruction. To comply with EU MDR (Medical Device Regulation) and other global standards, eIFUs must be accessible and understandable in the official language(s) of each target market.
Regulatory Requirements for eIFU Translations
The EU Regulation outlines strict rules for providing instructions in appropriate languages. Here’s what manufacturers must ensure:
Translation vs. Localization: What’s the Difference?
Translation is the direct conversion of text from one language to another.
Localization adapts content to suit the cultural, regulatory, and linguistic expectations of the local market.
For eIFUs, both are required. It's not enough to translate the words; regional healthcare practices, terminology, date formats, and even legal disclaimers must also be carefully considered. The right document translation services for the life science and medical technology industries can partner with you to ensure that translations are done effectively and efficiently. The right solution should give you confidence that your complex document translations are accurate, culturally relevant, and regionally appropriate.
Expert Tips for Translating and Localizing eIFUs
1. Use Subject-Matter Expert Translators
eIFUs contain technical terminology related to medical devices, anatomy, and procedures. Make sure your translator or your selected translation partner’s translators have life sciences or medical device backgrounds to ensure accuracy and compliance.
2. Implement a Terminology Management System
Use a Translation Memory (TM) and terminology glossary to maintain consistency across product lines and documentation. This speeds up future translations and reduces the risk of error.
3. Validate Layout and Usability in All Languages
Digital formatting can break when translated into languages with longer words or different character sets. Always check that your user interface, icons, and menus remain intuitive in every language.
5. Keep Regulatory Readiness in Mind
Ensure your eIFUs meet the local authority requirements (e.g., Notified Bodies in the EU or FDA e-labeling rules in the US). Maintain documentation that shows your translation process, linguist qualifications, and quality assurance protocols.
Common Mistakes to Avoid
How Ribolexi Can Help
At Ribolexi, we specialize in translation and localization services for medical devices, including full compliance support for eIFUs. Our approach includes:
✅Native-speaking translators with device-specific expertise
✅ISO-certified quality assurance workflows
✅Secure handling of sensitive documentation
✅Multilingual formatting and usability testing
Whether you’re preparing eIFUs for EU MDR compliance or launching a product in a new global market, we help you do it right the first time.
Need Help Translating Your eIFUs? Contact Ribolexi today to schedule a free consultation and learn how we can support your next launch with compliant, high-quality translation.
Your inquiries are important to us, and we're here to help. To get in touch, fill out the form on the right and expect a prompt, personalized response from one of our translation experts.
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