In recent years, the European Union medical device market has moved towards meeting new and stricter requirements. Regulations (EU) 2017/745 and (EU) 2017/746 created new rules that apply the same across member states. This means that devices sold in other member states are suitable for sale in Estonia.
However, attention should be paid to the information that accompanies the device. It must be provided in the language or languages specified by the member state. In Estonia, in the case of a device manufactured for a professional user, the information in English may be acceptable upon the user's consent, but the device intended for a lay user must be accompanied by information in Estonian.
This requirement has proven to be a significant obstacle for manufacturers and local distributors. Namely, the Estonian market is small and manufacturers prioritise entering the markets of larger countries. At the same time the Estonian market is largely dependent on manufacturers operating elsewhere. Together with the already much stricter requirements, all this has led to a decrease in the range of available devices both in Estonia and in the European Union in general.
With the aim of explaining to foreign manufacturers the language requirements in force in Estonia and different ways to comply with them, the State Agency of Medicines has prepared an explanatory letter.
We encourage parties operating in Estonia, but mainly distributors, to make use of this in their communication with manufacturers.
All questions are welcome to the address [email protected] of the Department of Medical Devices at the State Agency of Medicines.
