Efficient IFU Updates, Terminology Alignment, and Structured Delivery for a Dermal Filler Product
A global medical device manufacturer preparing for CE marking under the EU Medical Device Regulation (MDR) partnered with NN Translations to update the Instructions for Use (IFU) and consumer-facing text for their aesthetic dermal filler product. The objective: to ensure full multilingual MDR compliance and seamless integration of updated content across 11 European languages.
With prior versions already available, the challenge was to execute precise updates, apply new regulatory content, and maintain terminology consistency, all within a tight timeline and a structured regulatory framework.
The Challenge
Even minor updates to MDR-regulated documentation involve rigorous procedures and introduce significant complexity in multilingual projects. This project required us to:
- Update a specific paragraph in 11 target languages without disrupting legacy translations
- Translate and deliver two standalone regulatory sentences intended for product packaging artwork
- Ensure all updates followed MDR-compliant terminology, structure, and phrasing
- Use track changes to ensure transparency, traceability, and clean reviewer handoff
- Provide a harmonized multilingual glossary of MedDRA-derived terms to guide all linguists
- Manage consistency in key terms (e.g., “implant card”, “sterile needle”) across legacy and new content
- Maintain clear project-specific instructions to guide translators and revisers, minimize deviation, and ensure audit readiness
Our Approach
At NN Translations, we followed our ISO 9001 and ISO 17100 certified processes to ensure traceability, linguistic accuracy, and regulatory consistency at every step.
- Targeted Linguistic Update Workflow
Our team coordinated 22 linguists (translators and revisers) across 11 languages. Translators were instructed to work directly in the existing IFUs, implementing only the relevant updates and using Track Changes with assigned usernames (e.g., translator_JS) for clear traceability.
- Text Strategy
To streamline workflows and improve client usability, we proposed that the two newly added sentences—intended for product box—be translated in a separate Excel file. This allowed the client to access and implement these elements quickly and independently.
- Glossary Preparation (MedDRA-Based)
We created a project-specific glossary, consolidating terms from the MedDRA database and past translations. All linguists were instructed to use this glossary for both the IFU update and artwork translations, ensuring consistency across content and languages.
- Project Instructions for All Stakeholders
To reduce rework and reinforce compliance, we issued clear, role-specific instructions for both translators and reviewers. These included guidance on how to apply Track Changes, handle deviations from glossary or source, and what to flag vs. what to edit—minimizing scope creep and ensuring regulatory focus.
- Quality Assurance and Consistency Checks
Reviewers checked all updates against the source file and ensured they were properly integrated into the surrounding text. Particular attention was paid to the consistent use of legacy terms, especially those appearing in earlier versions of the IFUs.
The Result
- 11 languages updated and delivered on time, ready for CE submission
- Separate bilingual artwork file prepared for faster implementation and layout integration
- MedDRA-based glossary successfully enforced across linguists and languages
- Terminology consistency maintained with legacy IFUs and brand preferences
- 100% traceability of edits via ISO-compliant Track Changes and structured review
- Client confidence enhanced through clear communication and proactive process design
Even a single-paragraph update can introduce regulatory risk if not handled with the right structure, tools, and oversight. At NN Translations, our certified processes, subject-matter expertise, and collaborative workflows ensure that medical device manufacturers can make timely updates without compromising on quality, compliance, or consistency.
Planning an IFU or leaflet update under MDR?
Let’s talk. NN Translations can support your product lifecycle needs with speed, structure, and strategic insight.