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Language Requirements

 

Article 4(4) of the directive allows member states to "require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use."

Consequently, the member states were required to specify in their implementing legislation the language to be used on any packaging and any labels. Naturally, although a number of options are provided, each country specified that their native language be mandatory.

Polmed-30

 

important notice

The directive provides that member states may require the accompanying information to a medical device to be in their national language or in another community language.All member states require that safety information be provided in their official language to ensure understanding by the final user.

 

 

 

 

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