FR-LANGUE
French language requirement (France)
Instructions for use and labelling must be in French
- Category
- National requirements
- Market
- France
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device, Class A IVD, Class B IVD, Class C IVD, Class D IVD
In practice
Under the Toubon Act, labelling, instructions for use and advertising must be in French. Non-compliance carries penalties. Certified translation is advisable.
Official sources
https://www.legifrance.gouv.fr/loda/id/JORFTEXT000000509481See where this text lands in your roadmap
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