Waltham, MA – June 19, 2025 – Lionbridge has released a new resource titled “EU MDR and IVDR Language Guidance”, designed to help medical device manufacturers and Economic Operators (EOs) understand and manage the language requirements under the EU’s Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR, 2017/746).
These regulations, which replaced earlier EU directives, mark a shift from pre-market controls to full life cycle compliance, significantly increasing the demand for precise multilingual documentation across Member States.
Pia Windelov, Vice President of Life Sciences Strategy at Lionbridge, led the development of the guide, emphasizing the role of language in both regulatory compliance and effective communication. “Our goal is to help manufacturers approach language strategically throughout the life of the device,” said Windelov.
Key Components of the Guidance
The document is divided into three main sections:
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Multilingualism in the EU Regulatory System: Contextualizes how language requirements function within the EU and their implementation across national authorities.
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Language Requirements Under MDR and IVDR: Offers a structured presentation of official language expectations and practical recommendations for device-related content.
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AI Life Cycle Language Strategy: Introduces approaches to using AI and large language models (LLMs) as part of a risk-based language strategy that meets regulatory and market demands.
The guide also highlights the need for plain language in light of new EU transparency and disclosure rules, presenting AI as a potential tool to support clarity and compliance.
Download and Access
“EU MDR and IVDR Language Guidance” is available now. For more information, visit Lionbridge Life Sciences.
About Lionbridge
Lionbridge partners with customers to break barriers and build bridges all over the world. For over 25 years, we have helped companies connect with their global customers and employees by delivering translation and localization solutions in 350+ languages. Through our world-class platform, we orchestrate a network of passionate experts across the globe who partner with brands to create culturally rich experiences. Relentless in our love of linguistics, we use the best of human and machine intelligence to forge connections with our customers’ clients. Based in Waltham, Massachusetts, Lionbridge maintains solution centers in 24 countries. Learn more at www.lionbridge.com.
Contact
- Morgen Myrdal: mediainquiries@lionbridge.com
- Social Media: LinkedIn
