There are requirements for the Norwegian language for medical devices in Norway, both for professional use and for general use, cf. section 4 of the Medical Devices Act and section 8 of the Regulations on Medical Devices.
The manufacturer must ensure that the device is accompanied by information
- regarding safe and correct use
- must be in Norwegian
It is the manufacturer’s responsibility to ensure that the information complies with the requirements described in
- MDR Annex I (23)
- IVDR Annex I (20)
The information on the labelling shall
- be impossible to delete
- easy to read
- easily understood by the user of the device
For details on which information is to be provided on the label and in the instructions for use, we refer to Annex I in MDR and IVDR.
Implant cards and information provided to patients with implants
Implant cards should enable the patient to identify the implanted device and provide access to important information related to the device.
- Special requirements for implant cards and information provided to patients with implants
- The information shall be in Norwegian
- It must be made quickly and easily accessible to the patient
- Updates shall be available via the manufacturer's website
- For a complete overview, see MDR Article 18
- For certain implants, exceptions have been made from the requirement for implant cards and information provided to patients, see Article 18 (3)
Exemption from the Norwegian language requirement
It is possible to apply for an exemption from the language requirement, cf. regulation on medical devices § 17. Please note that the exemption from the requirement for the Norwegian language is interpreted strictly and the manufacturer must submit an application to the Norwegian Medicines Agency with the arguments for the exemption.
The application must contain the following information:
- Background for the application
- Name of the device and description of its intended use
- EU Declaration of Conformity and EC-certificate from the notified body (for devices in higher risk class)
- Name of the organisation that will handle the device
- Statement from the organisation on safe and proper use without Norwegian instructions for use
- A copy of the instructions for use and the labelling
The Norwegian Medicines Agency will take into consideration:
- The need for the device
- Whether there are other corresponding devices on the market that fulfil the requirements
- Whether the situation of a particular patient / patient group indicates that an exception should be granted
- Whether the user of the device is a professional
- Whether safe and correct use is ensured
The application should be marked with “Application for exemption from the language requirement” and sent to meddev-no@noma.no.
Technical documentation and EU Declaration of Conformity
Manufacturers and other economic operators who sell or wish to place medical devices on the Norwegian market shall, at the request of the Norwegian Medicines Agency, provide all information and documentation necessary to show that the equipment complies with the requirements in Norwegian or English, cf. the Regulation on medical devices § 12.
Service Manual
The service manual is usually not covered by the Norwegian language requirement.
Software
There are no special software requirements.
The manufacturer must ensure that the software is in Norwegian and provides information on safe and secure use.
Electronic instructions for use
For certain types of medical devices, the manufacturer is permitted to distribute the device with electronic instructions for use. The information in the electronic instructions for use must be in Norwegian.
For detailed information, see electronic instruction.
