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What Is EU MDR and Why Accurate Translation Matters

Regulation (EU) 2017/745, known as the European Union Medical Device Regulation (EU MDR), establishes a unified framework for ensuring the safety and performance of medical devices marketed in the EU. It replaces the former Medical Device Directive (MDD) and introduces stricter requirements across clinical evaluation, post-market surveillance, and transparency.

A key component of EU MDR compliance is the obligation to provide multilingual documentation. Manufacturers must translate critical regulatory content into the official languages of each EU member state where the device is marketed. This includes clinical evaluation reports (CERs), summaries of safety and clinical performance (SSCPs), instructions for use (IFUs), labeling, and other technical documentation.

Accurate and consistent translation is not optional. It is essential to meeting notified body expectations, enabling CE marking, and avoiding regulatory delays. Poor translation quality can lead to rejected submissions, nonconformities, or even product recalls. For high-risk Class IIb and Class III devices in particular, linguistic precision is critical to demonstrating clinical and regulatory validity.

At Sesen, we provide specialized translation solutions designed specifically for EU MDR submissions. Our linguists combine medical subject matter expertise with regulatory fluency to deliver submission-ready content that meets the strictest quality and compliance standards.

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End-to-End Language Support for EU MDR Documentation

End-to-End Language Support for EU MDR Documentation

Sesen delivers comprehensive translation services tailored to the European Medical Device Regulation (EU MDR 2017/745), helping global manufacturers meet strict linguistic and documentation requirements for CE marking. Our solutions are purpose-built for regulatory accuracy, audit readiness, and market authorization across all EU member states.

We work with professional native translators who possess deep expertise in medical terminology and European regulatory frameworks. Every project is managed under ISO 17100, ISO 13485, and ISO 9001:2015 certified quality systems to ensure traceable, high-accuracy deliverables.

Our teams support translation in over 100 languages and seamlessly integrate with your regulatory workflows and quality management system (QMS). Whether preparing new submissions or updating post-market files, Sesen ensures linguistic consistency, technical accuracy, and complete compliance with MDR expectations.

We translate all required EU MDR documents, including:

Translations of CERs require deep understanding of clinical data, scientific literature, and regulatory structure. Our linguists ensure alignment with MDCG guidelines, maintaining technical accuracy and consistency across all evidence and rationale provided to support device safety and performance.

We deliver clearly structured translations of SSCPs for both professional users and patients, tailored to meet the dual audience requirement under MDR Article 32. Terminology is adjusted appropriately to match the literacy level of each target user while remaining compliant with regulatory standards.

PMS documentation is critical for maintaining CE marking. Our translation process ensures clarity, completeness, and alignment with the manufacturer’s risk management and vigilance systems, enabling effective communication with notified bodies and national authorities.

We translate PSURs with full adherence to MDR Article 86 and MDCG expectations. Our linguists are trained to maintain consistency across benefit-risk assessments, trend analysis, and field safety corrective actions across all languages and jurisdictions.

Sesen provides localized IFU translations that meet Annex I, Chapter III of the MDR. We adapt technical content for device users while maintaining regulatory clarity, ensuring that layout, warnings, and safety instructions remain precise and user-friendly in each language.

We support multilingual labeling compliant with Annex I, Section 23 of EU MDR. Our process covers everything from UDI placement to warnings, symbols, and environmental handling requirements, using in-context review and label QA tools to reduce the risk of misinterpretation.

Translations of the DoC are handled with legal and regulatory precision to reflect the official attestation of conformity. We maintain consistency with other MDR documents and align language with notified body expectations across all EU languages.

We translate complex risk documentation such as FMEAs, hazard analyses, and risk control measures, preserving technical consistency and traceability. Our linguists are trained to handle detailed terminology and formatting to meet ISO 14971 alignment.

Our team provides language support for UDI data elements and free-text fields submitted to the EUDAMED database. We ensure content is translated precisely for both machine-readable and human-readable components, maintaining compliance with data entry protocols and language requirements.

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Trusted by Medical Device Companies Worldwide

Trusted by Medical Device Companies Worldwide

Sesen brings deep regulatory knowledge to every translation project, helping manufacturers navigate the evolving requirements of the European Medical Device Regulation with confidence. Our linguists and regulatory specialists maintain working familiarity with the full suite of Medical Device Coordination Group (MDCG) guidance documents that inform current translation expectations.

We understand what notified bodies look for in translated content, from the formatting of clinical evaluation data to the clarity of safety information presented in patient-facing documents. Our team monitors ongoing updates to MDR implementation guidelines and adjusts our workflows accordingly to support regulatory accuracy and audit readiness.

Whether you are preparing a first-time CE marking submission or updating files under ongoing vigilance and post-market requirements, we offer translation support for all device classifications and risk levels. This includes Class I, IIa, IIb, and III devices, as well as in vitro diagnostics and drug-device combination products. Our tailored approach helps streamline the review process and ensures your multilingual documentation meets the highest regulatory standards across the European market.

Quality-Focused Translation Workflows

At Sesen, our translation process is purpose-built to support the strict accuracy, consistency, and traceability required for EU MDR compliance. Each project begins with a detailed analysis of the source files, during which we extract key terminology and identify any regulatory references or product-specific language that must remain consistent across documents.

Our production workflow uses a dual-linguist model, where an experienced medical translator produces the initial draft, followed by a full review conducted by an independent in-country linguist. This two-step translation and revision process ensures technical accuracy and local regulatory alignment in each target language.

We work closely with clients to incorporate approved glossaries and style guides, which are especially important for maintaining consistency across multiple MDR documents such as CERs, IFUs, and labeling content. When required, we also provide back translation and reconciliation services for critical patient-facing or regulatory-sensitive materials, along with full linguistic validation for user testing or regulatory audits.

Every translated deliverable is formatted and reviewed through a final quality assurance stage, checking for regulatory terminology, layout compliance, and submission readiness. Our quality system is ISO 17100, ISO 9001:2015, and ISO 13485 certified, supporting full documentation control and traceability for notified body audits and regulatory reviews.

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Life Sciences Focus. Regulatory Precision.

Life Sciences Focus. Regulatory Precision.

Sesen is exclusively dedicated to life sciences translation. This specialized focus allows us to deliver unparalleled expertise in supporting regulatory submissions for medical devices across global markets. Our linguists are not generalists. Each translator is trained in medical and regulatory content, with hands-on experience translating EU MDR documentation including CERs, IFUs, SSCPs, and PMS reports.

We combine regulatory knowledge with operational efficiency. Our project workflows are designed for speed without compromising accuracy, offering fast turnaround on high-volume content while maintaining traceability and linguistic consistency. Clients benefit from transparent pricing models, enabling predictable budgeting and cost control throughout the product lifecycle.

Every project is managed by a dedicated Sesen project manager who serves as your single point of contact. Regular progress updates, milestone tracking, and quality checkpoints ensure on-time delivery and complete visibility.

All translations are processed and stored on our secure, AWS-hosted infrastructure with full GDPR compliance. This guarantees data privacy and system reliability, meeting the security expectations of medical device manufacturers and notified bodies throughout the EU.

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Integrated Language Solutions for Medical Devices

Integrated Language Solutions for Medical Devices

In addition to EU MDR documentation, Sesen provides a full suite of specialized translation services to support the entire medical device product lifecycle. From development through post-market surveillance, our language solutions help ensure compliance, clarity, and consistency across all markets.

  • Translation services for legally required documents with certification statements. Ideal for submissions to regulatory authorities, notified bodies, and health agencies across the EU and globally.
  • Multilingual labeling solutions for primary packaging, inserts, and over-labels. Ensures consistency with MDR Annex I requirements and device usability standards across all EU languages.
  • Accurate and user-centric translations of Instructions for Use, tailored to meet Annex I, Chapter III of EU MDR. Supports both printed and digital formats for diverse device types.
  • Drug–Device Combination Translation
    Specialized translation services for combination products regulated under both medicinal and device frameworks. Aligns with EMA and MDR requirements for packaging, IFUs, and clinical content.
  • Desktop publishing and in-context layout review for translated materials. Includes regulatory label compliance, visual QA, and file formatting across all EU language versions.

Sesen’s integrated workflows help streamline translation, review, and delivery across complex device documentation. Each service is backed by our ISO-certified processes and supported by linguists with deep regulatory expertise.

EU MDR Translation FAQs

Yes. Notified bodies and EU competent authorities often request certified translations for regulatory documentation, particularly for clinical evaluation reports, IFUs, and declarations of conformity. Sesen provides certified translations that include translator credentials and signed statements of accuracy in accordance with ISO 17100 standards.

We use client-approved glossaries, style guides, and translation memory tools to maintain consistent terminology across all EU MDR documents. Our linguists are trained to apply standardized regulatory language and medical device terminology, ensuring alignment with prior submissions and reducing the risk of discrepancies during review.

The required languages depend on the countries where the device will be marketed. Each EU member state mandates that user-facing content, including IFUs and labeling, be translated into its official language. Sesen supports translation into all 24 official EU languages, including localized variants where applicable.

Yes. We offer expedited translation services for urgent regulatory submissions and post-market documentation updates. Our scalable workflows and experienced linguists allow us to handle compressed timelines without compromising quality or compliance.

We collaborate closely with clients that interface with notified bodies, clinical research organizations, and regulatory consultants. Our teams understand the formatting, structure, and language preferences commonly required by regulatory reviewers, helping ensure smoother submission processes and fewer revision requests.

Request a Quote or Speak with a EU MDR Translation Expert

Whether you are preparing initial documentation for CE marking or updating post-market surveillance files, Sesen provides the specialized language support needed for full EU MDR compliance. Our team of regulatory translation experts is ready to deliver accurate, audit-ready content on time and in every required language.

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