Language requirements

Language requirements

Medical devices are required to have markings and instructions that ensure their safe use. The manufacturer’s contact details must be provided either on the device or package.

Instructions and other information accompanying medical devices must be in Finnish, Swedish or English. Information intended for users or patients to safely operate a device must be in both Finnish and Swedish.

Instructions and markings in respect of medical devices intended for self-testing must be in both Finnish and Swedish.

(Medical Devices Act 629/2010 article 12)