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Why IVD Translation Matters

Why IVD Translation Matters

Accurate translation of in vitro diagnostic (IVD) documentation is critical for regulatory approval, patient safety, and successful global commercialization. As diagnostic technologies become increasingly complex and markets more diverse, multilingual content must meet both linguistic precision and strict regulatory requirements.

Regulatory bodies such as the European Commission (under IVDR), the US FDA, and Japan’s PMDA require IVD manufacturers to submit language-specific documentation that complies with local standards. Errors or inconsistencies in translation can delay product approval, compromise clinical interpretation, and expose manufacturers to compliance risks.

Mistranslations in IFUs, labels, or clinical performance data can directly impact diagnostic accuracy, leading to misinformed healthcare decisions and potential harm to patients. These risks are especially acute in highly regulated markets and for high-risk devices.

Sesen specializes exclusively in life sciences translation. Our deep understanding of regulatory frameworks and diagnostic terminology ensures that every IVD document we deliver meets the highest standards of quality, compliance, and clarity across all target languages.

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Types of IVD Documents We Translate

Types of IVD Documents We Translate

Comprehensive Support for Every IVD Lifecycle Stage

Sesen provides comprehensive, end-to-end translation support for all document types required across the in vitro diagnostic (IVD) product lifecycle. From early-stage development to regulatory submission and global commercialization, our specialized linguists and regulatory experts ensure accuracy, consistency, and compliance in every language and format.

We translate the following IVD materials with precision and regulatory alignment:

Regulatory-compliant translations of user instructions for diagnostic devices, aligned with IVDR Annex I and local language requirements. Includes content for healthcare professionals, laboratory staff, and lay users.

Translation of IVDR-mandated SSPs covering device description, intended use, risk-benefit profile, and clinical evidence. Delivered in submission-ready formats for notified body review.

Multilingual labeling and packaging translation services, including region-specific regulatory statements, symbols, barcodes, and unique device identification (UDI) data.

Accurate translation of technical files required under IVDR Annex II and III, including risk management reports, performance evaluations, and design verification data.

Translation of protocols, validation reports, and performance study findings used to demonstrate diagnostic sensitivity, specificity, and reliability in regulatory submissions.

Translation of surveillance plans, PMPF reports, and vigilance documentation, supporting ongoing IVDR compliance and market monitoring requirements.

Certified translations of EU declarations of conformity, self-certifications, and manufacturer responsibility statements required for device registration.

Translation of materials related to diagnostic tests linked to targeted therapies, including cross-labeling, test reports, and regulatory documentation for co-developed products.

Localization of user interfaces, electronic forms, test result summaries, and consent materials designed for patient interaction and digital diagnostics.

Multilingual translation of lab protocols, internal training guides, and procedural documentation for diagnostic laboratories and field technicians.

Sesen supports over 150 languages and adapts translations to meet the linguistic, regulatory, and cultural needs of each target market. Our workflows integrate terminology management, in-country review, and formatting compliance to ensure every document is submission-ready.

IVDR and Global Regulatory Expertise

IVDR and Global Regulatory Expertise

Sesen brings deep regulatory expertise to every IVD translation project, helping manufacturers meet complex global requirements with precision and confidence. Our services are tailored to align with evolving regulations across key markets including the EU, United States, Canada, and Asia-Pacific.

Under the European Union In Vitro Diagnostic Regulation (IVDR), manufacturers must provide clear, accurate translations of all user-facing documentation. Annex I, Section 23 mandates that Instructions for Use, labels, and safety information be available in the official language(s) of each target member state. Translation quality directly impacts conformity assessments, notified body reviews, and CE marking.

For IVD devices entering the US market, Sesen provides translation support in compliance with FDA 21 CFR Part 809, which governs labeling for in vitro diagnostic products. We also support Health Canada’s bilingual documentation requirements, including French-language packaging, labeling, and user instructions for Class II to IV devices.

Sesen translates IVD documentation for regulatory submission to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and other Asian authorities. Our linguists are trained in the terminology and submission formatting standards required in Japanese, Korean, Chinese, and other languages specific to Asia-Pacific markets.

All translations follow certified processes aligned with ISO 13485 (quality management systems for medical devices) and ISO 17100 (translation services), ensuring full traceability, risk mitigation, and linguistic accuracy. These standards support audit readiness and document control compliance.

Translation requirements vary based on IVD device classification. Higher-risk classes (Class C and D) often require additional scrutiny, in-country linguistic review, and earlier submission of multilingual documents. Sesen adapts workflows to meet these risk-based regulatory expectations.

Each country imposes specific language requirements. EU member states, for example, may demand full translation of technical and marketing content in their official languages. Similarly, Quebec mandates French for commercial distribution in Canada. Sesen’s team ensures that every deliverable adheres to country-specific language laws and healthcare regulations.

Our IVD Translation Process

Sesen follows a structured, quality-focused process specifically designed for in vitro diagnostic (IVD) documentation. Our workflow integrates regulatory insight, linguistic accuracy, and technical formatting to deliver submission-ready translations that meet IVDR, FDA, and other international requirements.

Each project begins with a detailed assessment of source files, target markets, device classifications, and applicable regulations. We identify document types, required languages, and review timelines based on jurisdiction-specific compliance needs.

We create or align with existing client glossaries, style guides, and terminology databases. This ensures consistent use of diagnostic-specific language and alignment with IVDR terminology, labeling conventions, and brand voice.

Professional native linguists with expertise in diagnostics and regulatory affairs translate all content. Our translators are trained in the language of IVD labeling, performance evaluation, and clinical safety documentation.

For high-risk or high-impact documents, we offer an optional in-country review and subject-matter expert (SME) validation to align with local regulatory expectations and usage norms.

Our DTP specialists prepare translated files for final use, applying region-specific formatting for packaging, labels, and IFUs. We maintain layout integrity for multilingual materials, including double-byte and right-to-left scripts.

We use SesenGPT and QA tools to verify terminology consistency, language accuracy, and formatting fidelity. This includes number checks, tag validation, and detection of context errors based on regulatory templates.

Final deliverables are submitted in the requested format, ready for regulatory submission or production. Optional change tracking and version control are available for multi-round updates or post-approval revisions.

Multilingual Coverage for Global Markets

Multilingual Coverage for Global Markets

Sesen delivers IVD translation services in over 150 languages, enabling diagnostics manufacturers to meet the regulatory and linguistic requirements of every target market. Our team understands not only the source and target languages, but also the formatting, cultural, and regulatory nuances that affect how diagnostic content is interpreted and approved globally.

We support:

Full compliance with IVDR language mandates across the European Economic Area, including required translations for IFUs, labels, and regulatory documentation in each applicable member state language.

Expert translation services for Japanese, Korean, and both Simplified and Traditional Chinese, with attention to region-specific terminology, character encoding, and submission formatting requirements for PMDA, NMPA, and MFDS.

Multilingual support for Spanish (Latin American variants), Brazilian Portuguese, Arabic, Farsi, and other regional languages common to diagnostic product registration and distribution.

Specialized layout and formatting services for right-to-left languages such as Arabic and Hebrew, ensuring correct orientation, punctuation, and visual alignment for labels and IFUs.

Full support for languages that require double-byte character sets or complex typographic rendering, including Chinese, Japanese, Thai, and Hindi. Our tools and QA processes maintain text integrity during layout and production.

Sesen’s multilingual capabilities are supported by ISO 17100-certified linguists and localization engineers with experience in diagnostic device compliance and regulatory submission workflows.

Why Choose Sesen for IVD Translations

Why Choose Sesen for IVD Translations

Sesen is a trusted partner for IVD manufacturers seeking accurate, compliant, and scalable translation solutions. With exclusive focus on life sciences and deep diagnostics expertise, we deliver high-impact multilingual support tailored to regulatory and market requirements worldwide.

We specialize exclusively in life sciences, giving us an in-depth understanding of medical, regulatory, and technical language used in diagnostics, clinical research, and laboratory workflows.

Our translation and quality assurance processes meet internationally recognized standards for translation services and medical device quality systems, supporting traceability and audit readiness.

Sesen has supported global IVD companies with translations for IVDR submissions, companion diagnostics, and multilingual product launches across more than 150 markets.

Every project is led by a dedicated life sciences project manager with knowledge of IVD regulations, document structures, and submission timelines. This ensures accurate scoping and seamless execution.

Whether localizing IFUs into 25 EU languages or managing post-market surveillance documentation across multiple jurisdictions, our global linguist network and production infrastructure scale to meet demand.

We manage the full localization lifecycle, from terminology management and translation to multilingual desktop publishing and in-country review. Our integrated approach reduces turnaround times and improves consistency across content types.

Use Case Highlights

Sesen partners with diagnostics manufacturers worldwide to support multilingual compliance, product launches, and regulatory submissions. Below are selected examples that demonstrate our capabilities across different IVD translation scenarios:

Managed the full translation and DTP of Instructions for Use, labels, and Summary of Safety and Performance (SSP) documents across 20 EU languages. Ensured alignment with IVDR Annex I and II requirements and delivered submission-ready files for Notified Body review.

Translated and localized critical documentation for molecular diagnostics linked to targeted cancer therapies. Scope included label content, cross-referenced IFUs, and regulatory declarations, tailored for multiple EU and Asian markets.

Delivered multilingual SSPs compliant with IVDR Annex II Section 6, including device description, intended purpose, clinical evidence, and risk-benefit information. Provided technical formatting and layout in accordance with each target country’s language and document presentation standards.

These use cases reflect our ability to scale across complex regulatory projects while maintaining linguistic precision, document integrity, and submission compliance.

Technology-Driven Human Translation for IVD Accuracy

Technology-Driven Human Translation for IVD Accuracy

At Sesen, translation is always led by experienced life sciences linguists. We enhance their work with advanced AI tools and secure infrastructure to increase accuracy, consistency, and efficiency—without compromising quality or regulatory compliance.

We offer machine translation post-editing (MTPE) for appropriate IVD content, such as internal reference materials and high-volume labeling, where cost-efficiency is prioritized without regulatory risk.

SesenGPT and integrated QA tools automatically detect terminology inconsistencies, numerical mismatches, and formatting issues across multilingual outputs, reducing manual error and rework.

Our linguists work within leading computer-assisted translation (CAT) platforms, including memoQ, Trados Studio, and XTM. These systems enable translation memory reuse, version control, and collaborative review across large-scale projects.

All client data is managed on AWS-hosted infrastructure, meeting enterprise-grade security standards. Our client portal supports secure file exchange, project tracking, and version history for full transparency.

Sesen’s technology-enhanced workflows are designed to support the work of trained linguists, enabling faster turnaround, better consistency, and high-quality output that meets global regulatory expectations.

Frequently Asked Questions (FAQs)

Medical devices are classified into several broad categories based on their intended use and risk profile. Common types include:

  • Non-invasive diagnostic devices (e.g., MRI scanners, ultrasound machines)
  • Surgical instruments and implants (e.g., pacemakers, orthopedic implants)
  • Therapeutic devices (e.g., infusion pumps, ventilators)
  • Monitoring and wearable devices (e.g., glucose monitors, ECG trackers)
  • In vitro diagnostic devices (IVDs)
    These include reagents, test kits, and instruments used to analyze blood, tissue, or other specimens outside the body to support diagnosis or treatment decisions.

IVDs are regulated separately from other medical devices under frameworks such as the EU IVDR or FDA 21 CFR Part 809. They require specialized documentation, including performance evaluations, labeling, and IFUs, all of which must be translated accurately for global compliance.

IVDR-compliant translation requires that all user-facing content, including Instructions for Use (IFUs), labels, safety information, and Summary of Safety and Performance (SSP) documents, be translated into the official language(s) of each EU member state where the IVD will be marketed. Translations must be accurate, consistent, and technically validated to meet Annex I and Annex II requirements of the EU IVDR.

Project timelines depend on the volume, document types, target languages, and regulatory requirements. On average, a standard IFU or SSP can be translated into 5 to 10 languages within 5 to 10 business days. Larger projects, such as full technical documentation across 20 languages, may require phased scheduling. Rush services are available for urgent regulatory deadlines.

Yes. Sesen offers optional in-country review by native-speaking regulatory subject-matter experts. This service helps ensure that translated content aligns with local expectations and regulatory language norms, reducing the risk of nonconformity during notified body or ministry of health evaluations.

Absolutely. Our multilingual desktop publishing (DTP) team formats and localizes IVD labels, packaging, and UDI content according to region-specific layout, symbol usage, and language spacing rules. We also validate formatting consistency and regulatory alignment as part of our final QA process.

Language requirements vary by country. Each EU member state mandates the use of its official language(s) for specific document types, including IFUs and labels. For example, Germany requires German, France requires French, and Belgium may require Dutch, French, or German depending on the region. Sesen provides guidance on applicable language requirements during project intake.

Related Services

Explore additional services that support your IVD documentation and global compliance needs:

Need Expert IVD Translation Support?

Partner with Sesen for accurate, compliant, and industry-specific IVD translations tailored to meet IVDR, FDA, and global regulatory standards. Whether you’re preparing for market entry, updating technical documentation, or scaling multilingual distribution, our team is ready to help.

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