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Understanding EU MDR and the Role of IFU Translations

The EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) have introduced more rigorous requirements for product safety, performance, and transparency in the European market. A core aspect of these regulations is the need to provide clear, accurate, and accessible Instructions for Use (IFUs)translated into the official language(s) of each EU member state where the product is distributed.

High-quality IFU translations are not just a matter of localization, they are a regulatory obligation tied directly to CE Marking compliance and post-market surveillance readiness. Manufacturers must ensure that IFUs meet the language and content requirements outlined in Annex I of the MDR and IVDR, particularly for high-risk and implantable devices.

At Sesen, we specialize in delivering EU-compliant IFU translations that are linguistically precise, technically accurate, and fully aligned with the latest MDR and IVDR standards. Our services help medical device companies achieve fast and successful market entry across the EU while maintaining full compliance with evolving regulatory frameworks.

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Why IFU Translation Is Required Under EU MDR

Under the EU Medical Device Regulation (MDR 2017/745), accurate translation of Instructions for Use (IFUs) is a legal requirement—not an optional step. Manufacturers must ensure that users in each target country receive essential safety and performance information in their official EU language, as outlined in MDR Article 10(11) and Annex I, Chapter III.

Article 10(11) mandates that manufacturers provide documentation and labeling in a language easily understood by the intended user or patient, depending on the country’s regulatory authority. Annex I, Chapter III further specifies that IFUs must be available in the language(s) accepted by the respective EU member state, and must include all relevant warnings, precautions, operating instructions, and disposal guidance.

Failure to comply with these multilingual requirements can delay CE Marking, block market access, or trigger costly recalls. Beyond compliance, clear and localized IFUs reduce the risk of user error, improve product safety, and support post-market surveillance.

Sesen provides EU MDR IFU translation services that meet all applicable MDR Annex I language requirements while aligning with the latest CE marking documentation translation standards. Our expert linguistic teams ensure your IFUs are accurate, consistent, and fully compliant for every EU country where your device is distributed.

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Languages Required for EU Market Access

To comply with the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), manufacturers must provide Instructions for Use (IFUs) and related documentation in the official language(s) of every EU member state where their products are marketed. This is a core requirement for CE marking and successful product registration.

The European Union recognizes 24 official languages, and each country may require one or more specific languages for regulatory documentation. While EUDAMED, the central European database for medical devices, sets a harmonized data reporting framework, local Competent Authorities still maintain the right to define acceptable language(s) for IFUs, labeling, and safety communications. These preferences may differ based on product class, user profile, or local healthcare regulations.

Failing to submit translations in the correct language can result in delays, rejections, or noncompliance penalties. Manufacturers must therefore account for country-specific language rules in their EU market strategy.

Sesen helps medical device companies navigate this complexity by delivering IFU translations tailored to each country’s language requirements, ensuring full MDR and IVDR alignment across all relevant jurisdictions.

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Languages Required by Country for MDR and IVDR Compliance

Country

Required Language(s)

Austria

German

Belgium

Dutch, French, German

Bulgaria

Bulgarian

Croatia

Croatian

Cyprus

Greek, Turkish

Czech Republic

Czech

Denmark

Danish

Estonia

Estonian

Finland

Finnish, Swedish

France

French

Germany

German

Greece

Greek

Hungary

Hungarian

Ireland

English

Italy

Italian

Latvia

Latvian

Lithuania

Lithuanian

Luxembourg

French, German, Luxembourgish

Malta

Maltese, English

Netherlands

Dutch

Poland

Polish

Portugal

Portuguese

Romania

Romanian

Slovakia

Slovak

Slovenia

Slovene

Spain

Spanish

Sweden

Swedish

Norway*

Norwegian

Switzerland*

German, French, Italian

*Although not EU member states, Norway and Switzerland are part of the European Economic Area (EEA) or maintain mutual recognition agreements, and often follow MDR/IVDR language requirements.

Sesen’s EU MDR Translation Expertise

Sesen brings deep regulatory experience to EU MDR and IVDR translation projects, having translated thousands of IFUs for medical devices across all risk classes. Our specialized teams understand the linguistic, technical, and compliance nuances required for MDR Article 10 and Annex I documentation, helping clients meet language obligations across all 27 EU member states.

We work exclusively with professional native translators who have subject matter expertise in medical device terminology, ensuring precision and regulatory accuracy in every language. Our linguists are trained to handle product-specific content, including surgical instruments, implantable devices, diagnostics, and digital health solutions.

Sesen also supports translation projects for legacy devices under transitional provisions, helping manufacturers update documentation to align with MDR and IVDR requirements ahead of notified body reviews.

Our processes are certified to ISO 17100 (translation quality management) and ISO 13485:2016 (medical device quality systems). Combined with our multilingual project management capabilities, we deliver compliant, scalable, and audit-ready solutions for companies seeking CE Marking and EU market access.

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Our MDR Translation Workflow

Sesen follows a structured, regulation-driven workflow tailored for EU MDR and IVDR compliance to ensure every IFU translation meets the highest standards of quality, consistency, and readiness for notified body review.

We begin by reviewing your IFU documents and technical files to evaluate format, language requirements, and regulatory scope. Our team identifies compliance-critical content and establishes project timelines based on target countries and device classifications.

Using validated glossaries, style guides, and client-approved reference materials, we align terminology with MDR-specific language and device classification standards. This ensures clarity and uniformity across all target languages.

Translations are completed by professional native linguists with expertise in medical devices and EU regulations. Each file undergoes in-country linguistic review and a secondary QA layer to verify alignment with MDR Article 10 and Annex I requirements.

We perform comprehensive checks for linguistic accuracy, formatting integrity, labeling compliance, and language-specific instructions. Our QA process ensures that translations are suitable for regulatory audits and end-user clarity.

Translated files are delivered in print-ready and submission-ready formats, including PDF, Word, InDesign, or XML, as needed. We support multilingual layout validation to ensure packaging and labeling meet both linguistic and technical compliance across all EU markets.

Sesen’s MDR workflow is built to scale, enabling fast turnaround while maintaining full control over translation quality and regulatory readiness.

Document Types We Translate for MDR/IVDR

Sesen provides end-to-end translation support for all documentation required under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). Our services cover the full range of files necessary for CE Marking, notified body submission, and post-market compliance.

We translate the following document types:

Full multilingual localization of IFUs, aligned with MDR Annex I and country-specific language requirements.

Learn more about our IFU Translation Services.

Translation of device labeling, packaging inserts, and outer box text in accordance with MDR labeling provisions and harmonized symbols.

See our Medical Device Labeling & Packaging Translation.

Patient- and public-facing summaries prepared for Class III and implantable devices, translated into all applicable EU languages.

Regulatory translations for CERs and supporting documentation submitted to notified bodies or Competent Authorities.

Explore our Clinical Evaluation Report Translation Services.

Clear, compliant translations of implant cards provided to patients, as required under MDR Article 18.

Localized patient-facing instructions and educational materials to support safe device use and improve health literacy.

Translation of Unique Device Identification (UDI) data, labeling, and electronic documentation submitted through EUDAMED.

Sesen ensures that all translated materials are linguistically accurate, technically consistent, and submission-ready for regulatory review in every EU member state.

Benefits of Partnering with Sesen

Sesen delivers high-impact language solutions that meet the rigorous demands of EU MDR and IVDR compliance. Our clients choose us for our regulatory precision, industry-specific expertise, and scalable infrastructure designed for global medical device operations.

Our optimized workflows and specialized linguists allow us to deliver high-quality translations within tight regulatory timelines. We reduce review cycles while maintaining full compliance with MDR Article 10 and Annex I.

Sesen supports translations into all official EU languages and CE Mark–relevant markets. Whether your device is distributed in 5 or 27 countries, we scale seamlessly to meet your localization needs without compromising quality or consistency.

We follow GDPR-compliant data protocols and use secure portals for document exchange. Confidentiality agreements and restricted access controls protect your regulatory and product information at every stage.

Each client is supported by a dedicated project manager who oversees scheduling, linguistic QA, terminology alignment, and regulatory formatting. We offer multiple review cycles tailored to your internal workflows and notified body expectations.

Upon request, Sesen performs in-context linguistic review of IFUs, labels, and packaging materials to ensure language accuracy in final design files. We also validate formatting and layout to meet local labeling standards and MDR visual clarity requirements.

Our end-to-end support helps medical device manufacturers streamline compliance, reduce regulatory risk, and accelerate access to EU markets.

Frequently Asked Questions (FAQ)

Below are answers to common questions related to EU MDR IFU translation and regulatory documentation compliance. These responses reflect current best practices and help clarify how Sesen supports medical device manufacturers with high-quality language solutions.

Under MDR 2017/745, all Instructions for Use (IFUs) must be translated into the official language(s) of each EU member state where the medical device is marketed. Local Competent Authorities define specific language requirements, and noncompliance may result in registration delays or market rejection. Sesen provides end-to-end support to ensure your IFUs meet all MDR Annex I language obligations.

The Medical Device Regulation (MDR 2017/745) applies to general medical devices, while the In Vitro Diagnostic Regulation (IVDR 2017/746) governs in vitro diagnostic devices such as test kits and lab equipment. Both regulations require multilingual documentation for CE Marking and include similar language obligations under Annex I. Sesen supports translation services for both MDR and IVDR documentation, tailored to each device category.

Yes. Upon request, we offer back translation and linguistic validation services to support regulatory submissions, especially when patient-facing materials or high-risk devices are involved. These services are aligned with ISO 17100 and can be customized to meet notified body expectations or sponsor requirements.

Case Study: Multilingual IFU Translation for Class III Device Submission

A leading global medical device manufacturer approached Sesen to support the translation of Instructions for Use (IFUs) for a Class III implantable device requiring simultaneous CE Marking submissions across 27 EU countries. The client faced strict notified body deadlines and needed a scalable, compliant solution to ensure regulatory approval under EU MDR 2017/745.

  • 27 official EU language translations
  • Device-specific terminology requiring validated glossaries
  • Print-ready and submission-ready file delivery formats
  • MDR-compliant formatting aligned with Annex I
  • Secure file handling under GDPR

We implemented a structured, multi-language translation workflow led by a dedicated project manager and supported by a team of certified medical translators with MDR regulatory experience. Our team:

  • Completed linguistic QA and formatting validation
  • Conducted in-context review for layout accuracy
  • Delivered all 27 languages within a compressed 3-week timeframe

The client successfully submitted all translated IFUs on schedule, passed notified body review without revision, and achieved CE Marking for EU-wide distribution. The project demonstrated Sesen’s ability to deliver fast, accurate, and fully compliant MDR translation services at scale.

Related Services

Sesen offers a full suite of specialized language solutions to support EU MDR and IVDR compliance beyond IFU translation. Explore our related services to strengthen your multilingual documentation and regulatory readiness:

  • Comprehensive translation solutions for Instructions for Use across all device classes and international markets.
  • Linguistic review of translated content within final layouts to verify accuracy, formatting, and regulatory alignment.
  • End-to-end translation support for technical files, clinical documents, and post-market surveillance reports.
  • Multilingual typesetting and formatting to deliver print- and submission-ready IFUs and labeling materials.
  • Creation and maintenance of medical glossaries and style guides to ensure consistency across all translated content.

These services work together to deliver fully compliant, high-quality documentation that supports successful CE Marking and EU market access.

Get a Free Quote for EU MDR IFU Translation

Ready to translate your IFUs for EU MDR or IVDR compliance?

Sesen makes it easy to get started:

  • Upload your IFU files securely through our encrypted portal
  • Consult with a regulatory translation expert on language requirements and formatting
  • Receive a tailored quote and turnaround schedule aligned with your submission timelines
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