Kiri

Dear Sandrine,

Language requirements for medical devices distributed in Estonia are set up in Medical Devices Act § 16 (3):

By the information related with a medical device, instruction for use and device labelling are meant usually.

Please note, that although information accompanying devices meant for professional use only can be presented in English, Estonian information has to be provided in case of user request.

Good morning,

I would like some information about languages in Estonia. For medical devices, what languages are authorised for instructions for use for professional User and the information for lay User?

Best regards

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