Intertranslations White Papers
Multilingual Content Under MDR: When Language Becomes Regulatory Evidence
A Practical Framework for Regulatory Affairs and Quality Assurance Professionals of Medical Devices
This White Paper examines how multilingual content, from IFUs and labels to SDSs, SSCPs and SaMD interface text, functions as regulatory evidence under EU MDR 2017/745. It guides Regulatory Affairs and Quality Assurance teams in understanding when translations become controlled records, what auditors implicitly expect and how to structure translation workflows that are compliant, traceable and audit-ready.
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At a Glance
Why Download this White Paper?
Know When a Translation Becomes Regulatory Evidence
Under MDR, translated content doesn’t stay a linguistic output for long. This White Paper clarifies the point at which IFUs, labels and other multilingual documentation become controlled records subject to versioning, traceability and change control, helping RA and QA teams avoid the ambiguity that leads to audit questions.
Build Translation Workflows That Hold Up Under Audit
Effective translation management goes beyond linguistic quality. This White Paper outlines how to structure translation as a regulated process: from qualified linguists and independent revision to terminology control and documented traceability, so multilingual content integrates smoothly into your QMS.
Qualify Suppliers with Confidence, Across Every Market
Choosing a language service provider is a compliance decision, not just a linguistic one. This White Paper details what auditors expect from supplier qualification: certified competence, secure handling, objective evidence and audit trails, so you can defend your choices when asked.
What you’ll Discover
⦿ How language requirements differ across the EU, US and other global markets
⦿ The point at which a translation becomes a controlled regulatory record
⦿ What auditors expect from a qualified language service provider
⦿ How to structure translation as a compliant, auditable process
⦿ Practical steps for treating language as a change-managed asset
Inside the White Paper
You’ll find a clear, practical framework for understanding how multilingual content fits within the MDR regulatory landscape, from regional language obligations to supplier qualification and audit-ready translation workflows.
Navigating Regional Language Requirements Across Markets
The White Paper maps how language obligations differ by jurisdiction, with MDR as the strictest common denominator for global manufacturers. It covers the EU’s requirement that information supplied with a device be available in each Member State’s official language(s), linked implicitly to the General Safety and Performance Requirements in Annex I. It also examines the US model, where the FDA imposes no multilingual obligation but manufacturers remain fully accountable for accuracy in any language provided and other markets such as Canada, Japan and China, where language requirements are tied directly to market authorisation.
Identifying When Multilingual Content Enters the QMS
The White Paper clarifies a question that frequently causes uncertainty for RA and QA teams: When does a translation stop being a linguistic output and become a controlled document? It explains that the trigger is not wordcount, device class, or market size, but intended use and regulatory reliance. This includes conformity assessment, market placement, safe and effective use,and audit or submission evidence. It also outlines the common gap that arises when translations are operationally complete but not yet formally integrated into document control systems.
Qualifying Suppliers as a Controlled External Process
The White Paper sets out what regulatory-grade supplier qualification actually requires, beyond language proficiency. It details the criteria RA and QA teams should apply when selecting a language service provider, including certified competence in medical devices and regulated content, structured workflows aligned with regulatory language requirements, secure handling of sensitive documentation, professional liability coverage and the ability to produce objective evidence such as translation certification, blind linguist CVs and audit trails.
Structuring Translation as a Regulated, Auditable Process
The White Paper walks through what a compliant translation workflow looks like under the combined lens of ISO 17100, ISO 13485 and MDR. It covers translation and independent revision by qualified, subject-matter-native linguists, structured linguistic and technical QA, controlled terminology resources, documented traceability and version history and MDR-compliant formatting. It also addresses linguistic drift as an often-overlooked risk and explains how treating language as a change-managed asset with translation impact assessments, curated translation memories and periodic legacy review, keeps multilingual content audit-ready over time.
About the author
Despoina Polyzoidou
Language Solution Manager, Intertranslations SA
With over seven years of experience in translation and localisation for regulated industries, Despoina’s focus lies on supporting international medical device companies with compliance-critical multilingual content. She specialises in medical and regulatory documentation aligned with MDR and IVDR requirements, supporting CE marking–related documentation and works closely with RA/QA teams to ensure linguistic consistency, clarity and integration of translated content into the wider technical documentation set.
Testimonials
Programme Director, Multinational Defence Supplier
“We needed a language partner who could support complex multilingual projects across UK, EU, and US defense frameworks. Intertranslations delivered flawlessly, including on NATO documentation. Their precision, discretion, and responsiveness gave us complete confidence from start to finish.”
Head of International Procurement, Government Client
“Their linguists understood the operational context and delivered with speed and accuracy. Communication was clear throughout, and the project was executed exactly as scoped — no surprises, just solid performance.”
Programme Manager, European Defence Contractor
“The quality of the translations exceeded expectations, particularly given the tight deadlines and technical nature of the material. We appreciated the clarity, consistency, and the team’s ability to handle sensitive content with discretion.”
Procurement Officer, Confidential Defence Client
“We greatly appreciated the precision, discretion, and speed of delivery. Your team felt like an extension of ours.”