A global medical device manufacturer preparing for CE marking under MDR contracted NN Translations to translate and localize the Instructions for Use (IFU) and consumer leaflet for their aesthetic product. The project involved translation and revision into 11 European languages, ensuring the materials met the requirements for multilingual compliance, user comprehension, and regulatory readiness under EU Medical Device Regulation (MDR).
With tight timelines and high expectations, our client relied on us to coordinate a multilingual team, deliver compliant and high-quality content, and navigate both linguistic and operational complexity across multiple markets.
The Challenge
MDR-compliant translation is far more than a linguistic task—it’s a regulated process requiring strict terminology alignment, clarity, and traceability. This project presented several core challenges:
- Coordinating 22 linguists (translators and revisers) with subject-matter expertise
- Ensuring MDR-compliant terminology and documentation structures
- Managing a robust revision and approval loop across 11 languages
- Maintaining terminological and stylistic consistency
- Flagging and addressing inconsistencies and formatting issues in the source text
- Delivering within tight timelines while ensuring compliance and accuracy
Our Approach
At NN Translations, our services are backed by ISOs certifications. We strictly followed these certified processes throughout the project to ensure quality, traceability, and client satisfaction.
Here’s how we handled this multilingual MDR challenge:
- Specialized Linguist Selection
We assembled dedicated translator–reviser teams for each language, selecting linguists with substantial experience in medical device content, MDR compliance and EMA standards. - Translation & Independent Revision
Each file underwent a two-step linguistic process: initial translation by a subject-matter expert, followed by an independent revision to ensure clarity, consistency, and full alignment with regulatory expectations. - Change Approval Loop
Revised files were returned to the original translators to accept or reject changes, ensuring accountability, linguistic alignment, and full traceability of edits—core principles of our ISO-certified workflow. - Terminology Alignment
Our team carefully monitored terminology consistency during translation and revision and addressed discrepancies as they arose. This approach reinforced our standard practice of establishing glossaries for MDR-compliant projects, ensuring harmonized use of regulatory and product-specific terms across all languages. - Source Review & Client Communication
We identified inconsistencies in term usage (e.g., “undesirable effects” vs. “side effects”) and formatting issues in the source text. We flagged these clearly to the client and applied harmonized solutions (such as correcting section references) across all languages. - Product Name & Branding
As agreed in advance, we retained the product name and brand placeholders in English in all target language versions to support global brand consistency and regulatory clarity. - Final QA & Delivery
We performed a final quality control check across all files, ensuring formatting, completeness, and compliance before final delivery—ready for regulatory submission. MDR compliance checklist—verifying terminology, structure, labeling references, and documentation format across all target languages.
The Result
11 languages delivered on time and in full compliance with MDR expectations
Consistency and traceability ensured through ISOs processes
Terminology alignment achieved across all versions
Client confidence strengthened through proactive quality management and transparent communication
Internal best practices reinforced, including glossary development and early issue detection
Multilingual MDR compliance requires more than accurate translation. It demands structured, certified processes, expert coordination, and a strong understanding of the regulatory landscape.
At NN Translations, our ISOs certifications are more than a formality—they are the backbone of the quality and consistency we deliver. We help medical device companies navigate the complex intersection of language, regulation, and risk—ensuring that every word supports safety, usability, and global market success.
Planning a multilingual MDR-compliant project?
Let’s connect. We’d be glad to support your next medical device project with clarity, consistency, and confidence.
info@nntranslations.com
We’re always looking to refine our approach.
What strategies have helped you ensure quality, consistency, and compliance in your multilingual medical or regulatory documentation projects?
