ES-LANGUE
Spanish language requirement (Spain)
Instructions for use and labelling must be in Spanish
- Category
- National requirements
- Market
- Spain
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
Labelling, instructions for use and website must be in Spanish. Regional languages such as Catalan or Basque are sometimes required depending on the region.
Official sources
https://www.boe.es/buscar/act.php?id=BOE-A-2017-15481See where this text lands in your roadmap
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