MDR Compliance: Why Medical Device Translation Requires More Than Language
Under MDR, translation is not just a linguistic task. It is part of controlled documentation. Texts such as labels, IFUs, packaging text, and other product information cannot be treated as “just translations”.
So in practice, translation must be handled like a controlled process, with things such as:
- Approved source text
- Version control
- Traceability of changes
- Review and approval steps
- QA checks
- Proof of what was changed, when, and by whom
When companies update their labels, they need more than just precise wording: they also require a robust process that ensures traceability, consistency, and documented quality control across all language versions. Even small changes can cause significant downstream challenges if workflows aren’t managed effectively.
That’s why label update projects call for a systematic approach. From aligning terminology and managing version control to conducting multilingual QA checks and ensuring final delivery, every step should help teams maintain clear records of control and minimize unnecessary rework.
We support MDR-related label updates with workflows designed for regulated environments. Our GTP platform provides centralized project management, real-time status tracking, budget control, reporting, role-based workflows, and integration with client systems, including CMS, DAM, e-commerce platforms, and corporate infrastructure. The AI ecosystem adds automation, traceability, AI-assisted checks, deadline control, reporting, and centralized data handling, while Smart LQA enables objective quality evaluation with real-time reporting and configurable review parameters.
Translation, in the MDR context, is not just about saying it correctly. It is about managing content in a way that stands up to scrutiny.
If your team is preparing MDR-related label, IFU or packaging updates, the translation stage should not be treated as a final step after the regulatory work is done. It needs to be part of the same controlled process: terminology, version control, multilingual QA, approval workflows and traceability across all target languages.
At Janus Worldwide, we help medical device companies manage the translation side of regulated documentation updates — so multilingual content remains consistent, controlled and ready for review.
Let`s discuss how we can make your regular translation workflows more predictable in terms of timelines and quality?
Business Development Director
Anna Gajzler
Anna is a seasoned and motivated business development professional with over 15 years of experience in selling localization and technology solutions. She enjoys connecting with experts in various areas of localization, which provides her with ample opportunities to collaborate and exchange ideas. Anna is an avid follower of Simon Sinek and his “Start with WHY” message. Additionally, she actively advocates Nonviolent Communication (NVC) in both her personal and professional endeavors.