Resources

Medical Device and IVD Resources

Practical guidance, case studies and educational resources to help medical device and IVD manufacturers optimise their regulated content, select appropriate translation workflows and prepare clear, consistent documentation for international markets.

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Under the EU MDR and IVDR, manufacturers must provide specified device information in the language(s) required by the Member State where the device is made available. Depending on the device and market, this may affect IFUs, labelling, implant cards, Declarations of Conformity, Field Safety Notices, SSCPs or SSPs, PSURs, and PMCF or PMPF documentation.

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Featured Resources

Guide (PDF)

How to Choose the Right Translation Provider for MDR/IVDR Compliance

A practical guide to evaluating medical device expertise, ISO-certified processes, terminology management, quality controls and regulatory documentation support.

Access the Medical Device Guide →

Best Practices

Best Practices for MDR/IVDR-Compliant Translation

Explore practical considerations for preparing medical device and IVD documentation for international use, including terminology management, workflow selection, independent revision, readability, stakeholder review, traceability and quality assurance.

Access the Medical Device Translation Best Practices Guide →

Article

IFU Content Optimisation and Translation Workflows

Source content quality directly affects translation quality, regulatory review and user understanding. This guide explains how IFU content optimisation can identify ambiguity, inconsistent terminology, structural issues and potential regulatory gaps before translation begins.

It also compares risk-based translation workflows, from translation and independent revision to enhanced workflows incorporating proofreading, in-country review or clinician review.

Explore IFU Content Optimisation and Translation Workflows →

Case Study

MDR Translation for 11 European Markets

Discover how NN Translations coordinated 22 specialised medical device linguists to translate and revise an IFU and patient leaflet for 11 European markets.

The case study covers dedicated translator–reviser teams, terminology harmonisation, source content review, local client and distributor feedback, documented traceability and final QA. All 11 language versions were delivered on time as fully reviewed and client-approved content ready for regulatory use.

Read the MDR Translation Case Study →

Our Support

How We Support MedTech Manufacturers

We combine specialised medical device translation, IFU content optimisation, terminology management, controlled quality workflows, readability and usability support, and regulatory expertise delivered through experienced consultants.

Our ISO 9001-certified quality management system and ISO 17100-certified translation processes support qualified specialist selection, independent revision, documented query resolution, terminology consistency, traceability and final QA.

Each workflow is tailored to the document type, intended users, risk level, target markets and applicable regulatory requirements. Depending on the project, it may include proofreading, spot checks, in-country or clinician review, reconciliation of stakeholder feedback and preparation of translation evidence records.

Explore Medical & Regulatory Translation →

Explore IFU Content Optimisation & Regulatory Support →

Explore Readability & Usability Testing →

ISO-Certified Quality

Our quality management system is certified to ISO 9001, and our translation processes are certified to ISO 17100.

View ISO 9001 Certificate →

View ISO 17100 Certificate →

For Clients

Client Resources

We have developed structured client and internal documentation to support transparent project preparation, controlled delivery and clear accountability.

Selected materials are available to prospective and existing clients upon request, according to their project requirements.

Project Preparation and Governance

Resources supporting project qualification, contracting, confidentiality and service expectations.

Pre-Project Translation Qualifying Questionnaire
Captures document type, intended users, target markets, language variants, review requirements, timelines and deliverables.

Service Level Agreement
Defines workflows, responsibilities, communication procedures, quality controls and service expectations.

Medical Device Translation FAQ Guide
Provides easy-to-understand answers about our expertise, quotations, workflows, deliverables, regulatory support and client collaboration.

And more...

Quality and Data Protection

Quality Manual
Describes our ISO-certified quality management and translation processes.

Quality Procedure for Handling Quality Concerns and Missed Deadlines
Defines escalation, investigation, corrective action and follow-up procedures.

Data Security and Confidentiality Manual
Explains how confidential information and personal data are protected.

Translation Evidence and Quality Records
Depending on the agreed scope, projects may include translation and revision records, approved glossaries, query logs, quality checklists, tracked stakeholder feedback, final QA records and supporting certificates.

And more...

Tell us which materials you would like to review or discuss your project requirements with our team.

Request Access to Client Resources Email Our Team

Keep Exploring

Explore More Medical Device Resources

Medical Device Insights

Discover articles addressing IFU content, translation workflows, regulatory terminology, readability, quality assurance and international content management.

Explore the Insights Hub →

Medical Device Webinars

Access educational sessions covering medical device translation, MDR/IVDR considerations, FDA and other regulatory guidance, IFU content optimisation, terminology and quality workflows.

Explore Medical Device Webinars and Workshops →

Medical Device Case Studies

Explore how we manage terminology, quality, stakeholder feedback and complex international delivery for regulated medical device content.

View Medical Device Case Studies →

Reference Library

Medical Device Translation Reference Library

The resources below support terminology research, regulatory-content preparation and translation decisions. The references relevant to an individual project depend on the device, document type, intended users and target markets.

EU Regulations and Language Requirements

EU Medical Device Regulation 2017/745
The MDR establishes the EU regulatory framework for medical devices. Article 2 provides regulatory definitions, while Annex I, Chapter III addresses information supplied with the device, including labelling and IFUs. The regulation can be viewed on EUR-Lex in all official EU languages and used as a reference for established regulatory phrasing.
Access the EU MDR on EUR-Lex →

EU In Vitro Diagnostic Medical Devices Regulation 2017/746
The IVDR establishes the EU regulatory framework for IVD medical devices and performance studies. Article 2 and Annex I, Chapter III provide definitions and requirements concerning information supplied by manufacturers.
Access the EU IVDR on EUR-Lex →

MDR and IVDR National Language Requirements
The European Commission publishes tables summarising language requirements established by EU Member States. Manufacturers should confirm the current national requirements applicable to each device, document and target market.
MDR Language Requirements for Manufacturers →
IVDR Language Requirements for Manufacturers →

UK and US Guidance

Medical-device projects intended for UK or US markets may also require consideration of relevant MHRA guidance and applicable FDA regulations and guidance.
MHRA Medical Device Guidance →
FDA Medical Device Guidance →

Medical Device Nomenclature

European Medical Device Nomenclature
The EMDN supports the registration of devices in EUDAMED and is used in connection with UDI-DIs, technical documentation sampling, post-market surveillance, vigilance and post-market data analysis. For EU projects, EMDN terminology should be prioritised where applicable.
Search the EMDN →
Access the EMDN Database →

Global Medical Device Nomenclature
GMDN provides device terms, definitions and classifications and may support terminology research in multiple languages. However, GMDN and EMDN are separate nomenclature systems and should not be treated as interchangeable. EMDN remains the relevant nomenclature for EU MDR/IVDR purposes.
Access the GMDN Database →

WHO MeDevIS
The WHO Medical Devices Information System is an open-access database containing device information associated with EMDN and GMDN codes. It can support research into corresponding device concepts and nomenclature codes.
Access WHO MeDevIS →

Adverse Event and Medical Terminology

IMDRF Adverse Event Terminology
The IMDRF terminology provides harmonised terms, definitions and codes for reporting medical device adverse events. It covers device problems, cause investigation, health effects and device components.
Access IMDRF Adverse Event Terminology →

MedDRA
MedDRA provides standardised medical terminology used in regulatory information and safety monitoring. It may support research into translated clinical signs, symptoms and conditions mapped to IMDRF adverse-event terminology. Its relevance should be evaluated according to the document and regulatory context.
Access MedDRA →

WHO ICD-11
ICD-11 provides internationally harmonised disease and health-condition terminology in multiple languages. It may serve as a supplementary reference when researching medical concepts or adverse event terminology.
Access ICD-11 →

EDQM Standard Terms
The EDQM database provides controlled terminology for pharmaceutical forms, routes of administration, containers and related concepts. It may be relevant to combination products and documentation containing pharmaceutical terminology.
Access the EDQM Standard Terms Database →

IFU, Labelling and Product Information Standards

ISO 20417
ISO 20417 specifies general requirements for information supplied by medical device manufacturers, including device identification, labels, packaging and accompanying information such as IFUs.

ISO 15223-1
ISO 15223-1 defines symbols used with information supplied by medical device manufacturers. Official or nationally adopted versions should be consulted where terminology accompanying symbols requires translation.

ISO 18113 Series
The ISO 18113 series establishes requirements for information supplied by manufacturers of IVD medical devices, including labels, symbols and IFUs for professional use and self-testing products.

IEC 62366-1
IEC 62366-1 addresses the application of usability engineering to medical devices and may be relevant when evaluating whether safety-related information can be understood and used effectively.

ISO 14971
ISO 14971 addresses medical device risk management and may provide important context for warnings, precautions, hazards and other safety-related content.

Selected MDCG Guidance

MDCG 2019-9 Rev.1 – Summary of Safety and Clinical Performance
Guidance concerning the content and presentation of the SSCP, including information intended for healthcare professionals and patients.
Access MDCG 2019-9 Rev.1 →

MDCG 2022-21 – Periodic Safety Update Reports
Guidance concerning PSUR requirements under the MDR and the presentation of post-market information.
Access MDCG 2022-21 →

MDCG 2023-3 – Medical Device Vigilance
Guidance on the vigilance system under the MDR, including incident reporting and associated terminology.
Access MDCG 2023-3 →

MDCG 2021-12 Rev.1 – EMDN Questions and Answers
Practical information about the purpose, structure, governance and use of the European Medical Device Nomenclature.
Access MDCG 2021-12 Rev.1 →

Questions

Frequently Asked Questions

Why is medical device translation different from standard translation?

Medical device translation requires specialised understanding of regulatory terminology, patient and user safety, usability, and technical communication. Inconsistencies or unclear wording may affect user understanding, regulatory review, safe product use and market access.

How do your workflows support regulatory readiness?

We apply controlled workflows incorporating qualified medical device linguists, independent revision, terminology management, documented query resolution and final QA. Our quality management system is certified to ISO 9001, and our translation processes are certified to ISO 17100 aligned with ISO 13485.

What is IFU content optimisation?

IFU content optimisation improves the clarity, consistency, terminology, structure, readability and translatability of Instructions for Use before translation. Where required, the workflow can include native English review, bilingual harmonisation and input from experienced regulatory affairs consultants.

How do you maintain terminology consistency across languages and product updates?

We create and maintain client-specific translation memories, approved glossaries, terminology resources and style guides. These assets support consistency across languages, documents and product versions while reducing repetitive work, review cycles and long-term translation costs.

Can your workflows accommodate our local teams and in-country reviewers?

Yes. Workflows can include review by local client teams, distributors, clinicians or regulatory specialists. Our linguists assess and reconcile their feedback, incorporate approved terminology and apply agreed changes consistently across the relevant documents and languages.

Discuss Your Medical Device or IVD Requirements

Schedule a call to discuss your medical device or IVD content, translation, IFU optimisation, usability testing or regulatory support requirements.