Hello Pooi,
There is no distinction in the translation of material across different components of a device packaging. In regards to carton labels and device labels, there a multitude of symbols (!SO 15223-1) which can be used allowing much of the material to be conveyed without needing to translate. Article 10 and Annex I make statements information must be in the Member States language but does not make a differentiation between carton labels and IFUs. There may be individual Member State requirements for local language, but I am not aware of any specifics.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-Nov-2021 17:52
From: Pooi Mun Tam
Subject: EU medical device language translation
May I know for EU Medical device labelling, which are the countries require Carton label & IFU translation and which countries just need IFU translation but not carton translation.
Please share some references as well.
Thank you. π
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Pooi Mun Tam
Singapore
Singapore
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