National language requirements

National language requirements

There are country-specific language requirements for the instructions for use and labelling within the EU/EEA. Finland's local language requirements have been presented in the national act: Medical Devices Act (719/2021), Section 5.

In Finland, the instructions for use of a medical device intended for professional use can be provided in Finnish, Swedish or English. 

However, the instruction necessary for the safe use of a device intended for consumer use must always be in Finnish and Swedish. Based on a risk assessment, the manufacturer assesses what information is considered necessary for safe use. The instructions for use for a home test must always be provided in Finnish and Swedish.

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Labelling and instructions for use

Language requirements for medical devices in finland (pdf)