February 14, 2021
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.
NoMA provides further details on Norwegian labeling and IFU rules
NoMA appended to this announcement several provisions for the preparation of Norwegian labeling and IFUs, in the service of clarifying and facilitating the process:
- The medical device manufacturer may establish an agreement with the importer or distributor to attach the Norwegian labeling and IFUs prior to delivery to the end user. Such an agreement must be available for submission to NoMA.
- Norwegian marking may be applied in the form of a self-adhesive label, by agreement with the manufacturer. Critical information, such as the product’s CE Mark or the manufacturer’s name and address, should not be covered up by the label.
- The manufacturer’s information in the labeling and IFUs should be reproduced in the Norwegian translation if it is originally written in another language. This information should be in the same location as the original marking/IFU, unless otherwise agreed with the manufacturer.
NoMA’s stated position on its website is that field safety notices (FSNs) issued to users to support the safe and effective use of healthcare products must also be written in Norwegian. The detailed requirement for medical device labeling in Norway, which has not been updated as of this time, is available in Norwegian here and in unofficial English translation here.
Resources from Emergo by UL for understanding the EU MDR and non-EU European markets:
- Customized regulatory pathway reports for smaller markets
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