Norwegian language requirement Information on the label and in the instructions for use must be in Norwegian, cf. the Regulation on Medical Devices section 8. MDR annex I section 23 states the information that must be provided in Norwegian. The information on the label must be impossible to erase, easy to read and easy to understand for the user of the device.
The language requirement applies for software. The manufacturer must ensure that all relevant information on proper and safe use is given in Norwegian language.
Buttons and keyboard components with single words etc. will be considered as symbols. Symbols do not require translation, but must be explained in the instructions for use. Examples: "On", "Off", "Load", "Enter", "Page Up" etc.
Electronic user manual
The information stated in an electronic user manual is covered by the Norwegian language requirement.
A service manual is normally not covered by the Norwegian language requirement.
Technical documentation and EU Declaration of Conformity
The manufacturer and other economic operators on the Norwegian market must, upon request from the Norwegian Medicines Agency, provide all necessary information and documentation, in Norwegian or English language, in order to prove that the device is in accordance with the relevant requirements, cf. the Norwegian Medical Device Regulation section 12.
If safe and proper use is ensured, the Norwegian Medicines Agency may grant an exemption from the language requirement in accordance with section 8 of the Norwegian Medical Device Regulation. The exemption is under strict interpretation.
The manufacturer may submit an application, presenting arguments on why the device should be exempted from the language requirements. The application shall contain the following information:
- Background for the application
- Name of the device and instructions for use
- EC Certificate (where appropriate) and the Declaration of Conformity
- Name of the user of the device, e.g. health institution, hospital etc.
- Statement from the user on safe and proper use without Norwegian label and instructions for use.
- A copy of the label/instructions for use
NoMA will take into consideration:
- The need for the device, including whether there are other corresponding/alternative devices on the market that fulfil the requirements, and whether there is time for translation
- Whether the device is needed for a specific patient/patient group
- Whether the user of the device is a professional or a lay person