Regulatory Developments: Language Requirements for Medical Devices in Europe 🌍
In August 2025, the European Commission published the third revision of the table of language requirements applicable to medical device manufacturers under Regulation (EU) 2017/745 (MDR).
Why are these changes happening?
The MDR allows Member States to determine, at the national level, the languages in which manufacturers must provide the information accompanying their devices (labeling, instructions for use, implant cards, declarations of conformity, user interfaces, SSCP, etc.).
The goal is to ensure safety and clear understanding by patients and healthcare professionals, while taking into account Europe’s linguistic diversity.
What’s Changing in 2025
The August 2025 revision includes, in particular, an update on Portugal, with a clarification of the language requirements in Decree-Law No. 29/2024 of April 5, 2024. Effective immediately:
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Information intended for patients must be provided in Portuguese.
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Certain information intended exclusively for professionals may be provided in English, subject to certain conditions.
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Graphical user interfaces (applications, software, etc.) must always include a Portuguese version, but English may be accepted as a supplementary language if it does not compromise user safety.
Challenges for Manufacturers
These developments underscore the importance of actively monitoring regulatory developments:
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Adapt the information to be provided to users to meet local requirements.
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Plan for translation costs.
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Ensure that end users (patients and healthcare professionals) have access to clear and understandable information.
👉 For players in the medical device sector, language compliance is not just an administrative requirement—it is also a major issue involving safety, trust, and access to the European market.
View the MDR – Language Requirements for Manufacturers – Rev. 3 (August 2025)