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Labelling and language requirements for medical devices

There are two general rules for the labelling and instructions for use of a medical device distributed in Estonia.

If the device is meant for lay user, everything accompanying the device shall be in Estonian (package and instructions for use).

  • For software: User interface in English is acceptable as long as the instructions for use is in Estonian with all steps/screens.

If the medical device is for professional use, it is required that the information strictly necessary for the safe use of a medical device for its intended purpose accompanying a medical device shall be presented in the Estonian language. The remaining information accompanying a device may be presented in another language of a Member State of the European Economic Area understandable to the potential user (English is most preferable).

The person who places the medical device on the market in Estonia or the distributor shall ensure the correctness of translation of the instructions of a medical device.

It is also considered good practice to add the name and address of the distributor to the labelling.