EU MDR Label Translation Requirements

Question: What are the translation requirements for product labels under the European Union (EU) Medical Device Regulation (MDR)? Do labels need to be translated into the languages of EU member states where products are marketed?

Answer: MedTech Europe, the European trade association for the medical technology industry, has published a guidance document on symbol usage for medical device labels. Using symbols rather than multiple translations on medical device labels should make labels more easily understood, and may also help save space on labeling. This guidance also provides context on which information should be included as a symbol on the label.

This article is current as of 2020-02-07.

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