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Labelling and language requirements for medical devices

According to the Estonian Medical Devices Act, the manufacturer of the medical device, relying on risk analysis, ascertains the information necessary for the safe use of a device for the intended purpose. The information accompanying the medical device being placed on the market, made available on the market, distributed and put into service in Estonia must be presented:

  • in the Estonian language and in an appropriate manner if the medical device is intended for the use of lay users;
  • in the Estonian or English language and in an appropriate manner if the medical device is intended only for the use of professional users;
  • in the language understandable to a specific user and in an appropriate manner in case of a custom-made medical device.

It is important to keep in mind that the professional user and the supplier of the medical device should agree beforehand in case the information accompanying the medical device will only be provided in English. The professional user still has the right to demand that the relevant information is made available in Estonian.

For medical devices that are placed on the market in compliance with regulation (EL) 2017/745 or (EL) 2017/746 the requirements for labelling and translation set out in these regulations must be met. This includes the requirements set out in Articles 16 in both regulations.