You are here

Labelling and language requirements for medical devices

The information on the sales packaging (including the product name, if applicable) has to be in the Estonian language. It is also considered good practice to add the name and address of the distributor to the labelling, if the product has been manufactured outside Estonia.

The minimum packaging information is required to ensure the safe and appropriate use of the medical device must be in Estonian and must be displayed in an appropriate manner, taking into account the knowledge of the potential user. Other information concerning the medical device may be in any other European Member State language (English is most preferable), provided it is understandable by the user. The same principles apply to products meant only for the Estonian internal market.