Norway – Norwegian language requirement will apply following MDR implementation

The Norwegian Medicines Agency (NoMA) has added language (link in Norwegian) on its website regarding the requirement that medical device labeling and instructions for use (IFU) be printed in the Norwegian language in order to be legally marketed in in the country. The expanded notice confirms that the language requirement will still apply following the implementation of the EU Medical Devices Regulation (MDR) on May 26, 2021. As a member state of the European Free Trade Association (EFTA) and part of the European Economic Area (EEA), Norway has taken steps to harmonize its own medical device regulations with the MDR and hence maintain privileged access to EU markets…