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ifu-localization-class-iii-medical-device

Project Overview

A leading U.S.-based MedTech company specializing in implantable cardiac devices engaged Sesen to localize Instructions for Use (IFUs) for their new Class III device. As part of the company’s strategic expansion into the European Union, the project aimed to support market authorization under the EU Medical Device Regulation (MDR 2017/745).

Given the high-risk classification of the device, the IFUs required precise, regulator-compliant translations into 24 EU languages to meet strict MDR requirements related to safety, performance, and usability. Sesen’s task was to deliver accurate and fully formatted IFUs that aligned with Annex I, Chapter III of the MDR, covering essential information such as intended use, contraindications, and device-specific handling instructions.

The project underscored the critical role of multilingual IFUs in ensuring patient safety, clinician understanding, and smooth regulatory approval across diverse EU markets.

The Challenge

The project involved localizing IFUs for a Class III implantable medical device, one of the highest-risk classifications under EU MDR. These devices require precise and consistent use of medical terminology to ensure patient safety and regulatory compliance. The IFU content was highly technical, containing complex procedure-specific instructions, safety warnings, and clinical performance specifications that demanded accurate linguistic representation in each target language.

A critical challenge was aligning terminology across related product families and legacy documents to ensure consistency and eliminate discrepancies that could trigger regulatory scrutiny. Sesen was also tasked with resolving variations in terminology used by different internal teams and prior vendors.

In addition, the client faced a narrow submission window with an upcoming EU notified body review. The localization work had to be executed swiftly while maintaining full alignment with MDR Annex I, Chapter III requirements, including language-specific formatting, labeling structure, and usability guidelines. Any delay or inaccuracy could compromise the device’s approval and planned launch timeline.

Our Solution

Linguistic and Technical Strategy

Sesen assembled a team of medically trained native linguists with proven expertise in cardiovascular device terminology and regulatory translation. Each linguist was fully versed in EU MDR 2017/745 requirements, particularly Annex I, Chapter III concerning IFU content and structure. To ensure consistency and accuracy, our team created a dedicated project glossary and terminology database, which was reviewed and validated in collaboration with the client’s Regulatory Affairs and Quality Assurance teams.

Workflow and QA Implementation

We implemented a structured, multi-step translation workflow designed for medical device documentation. The process included initial translation, independent bilingual review, in-context quality assurance, and final desktop publishing (DTP) validation. Sesen’s proprietary AI-assisted tools supported the linguistic team by automatically detecting terminology inconsistencies, mistranslations, and structural issues early in the process. This reduced manual rework and accelerated review cycles while improving output quality.

Regulatory and Layout Compliance

To meet EU regulatory expectations, all translated IFUs were fully aligned with MDR-compliant labeling and formatting standards. This included adherence to language-specific conventions, medical symbols, and presentation requirements. Final QA was performed within the actual layout files to validate content in context. Special attention was given to preventing layout issues such as orphaned text, broken line structures, and misnumbered sections—common pitfalls that can result in regulatory rejections.

This integrated approach ensured submission-ready IFUs that met both linguistic and technical compliance standards across all 24 target languages.

Results

Sesen successfully delivered a fully localized, submission-ready EU IFU package in 24 languages, each formatted and validated to meet stringent MDR compliance standards. The translations were approved by the client’s notified body with no revisions required, an outcome that reflects the precision and regulatory alignment of our linguistic and technical workflows.

By implementing early-stage terminology harmonization and conducting QA directly within the layout files, we reduced the client’s quality assurance cycle by 30%. This proactive approach minimized review iterations and prevented last-minute formatting errors often flagged during regulatory assessment.

As a result, the client met their EU submission deadline and achieved timely approval for market entry. The Class III medical device was successfully launched across major European markets without regulatory delays, positioning the client to meet revenue goals and improve patient access to critical cardiovascular technologies.

Key Takeaways

  • Sesen’s team of native linguists with specialized medical device knowledge plays a vital role in producing accurate, regulator-ready IFUs for high-risk Class III products. Their familiarity with EU MDR terminology and clinical language ensures both linguistic precision and compliance.
  • Harmonizing terminology across product families and legacy materials supports consistency, reduces internal review time, and lowers the risk of discrepancies that could delay regulatory approval. This approach is especially important when managing multilingual submissions under tight timelines.
  • Our end-to-end localization process combines rigorous linguistic QA with in-context desktop publishing review. This integrated workflow enables Sesen to deliver MDR-compliant IFUs that meet ISO 13485:2016 quality standards and are ready for direct submission to notified bodies.

Related Services

Clients seeking IFU localization for high-risk medical devices often benefit from Sesen’s broader suite of specialized language solutions for the life sciences sector:

  • IFU (Instructions for Use) Translation
    Professional translation of complex IFUs in accordance with EU MDR and ISO 13485:2016, performed by native linguists with medical device expertise and supported by rigorous QA workflows.
  • Medical Device Labeling Translation
    End-to-end localization of multilingual labeling content, including UDI, safety information, and technical symbols, tailored for global compliance and ready for notified body submission.
  • Label Review & In-Context QA
    In-layout linguistic validation to ensure label translations maintain accuracy, formatting integrity, and regulatory conformity before finalization or print.
  • Regulatory Translation Services
    Translation of technical documentation, regulatory dossiers, and labeling content for EMA, FDA, and other global health authorities, with built-in QA and terminology harmonization.

These services are designed to support full lifecycle compliance, from initial labeling to final submission, helping clients streamline regulatory processes and accelerate market access.

Client Testimonial

“Sesen’s localization team demonstrated deep regulatory knowledge and exceptional linguistic precision. Their understanding of EU MDR requirements and attention to detail in medical device documentation were evident throughout the project. The structured workflow, proactive communication, and in-context quality checks gave our regulatory team full confidence in the submission package.”

— Regulatory Affairs Manager, U.S. Medical Device Manufacturer

Need IFU Localization Support for EU MDR Submissions?

Partner with Sesen for precise, regulator-aligned IFU translations in 24 EU languages. Our expert linguists and integrated QA workflows help you meet MDR requirements, minimize approval risks, and accelerate time to market.

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