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February 13, 2026
Approximately 5 minutes
Language Requirements and Information Supplied with Medical Devices in Norway
Language Requirements and Information Supplied with Medical Devices in Norway
1. Purpose
The manufacturer must ensure that the device is accompanied by information that identifies the device and the manufacturer. The information must also provide information on safe and secure use, adapted to the relevant user of the device. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/language-requirements-and-information-following-the-medical-device
2. Scope
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. This applies to information regarding safe and correct use, which 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) or IVDR Annex I (20). https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/language-requirements-and-information-following-the-medical-device
3. Requirements for Instructions for Use
The devices must be supplied with instructions for use, mainly in paper format. Devices in Class I and Class IIa are excluded, if the devices can be used safely without instructions for use. The manufacturer must make a risk assessment and justify how the devices can be used in a safe manner without instructions for use. For certain types of devices, the user may obtain the instructions for use in electronic form. The information in the electronic instructions for use must be in Norwegian. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/language-requirements-and-information-following-the-medical-device
4. Electronic Instructions for Use
Some types of medical devices may be delivered to the user with electronic instructions for use instead of paper format. Electronic instructions for use are meant to be instructions for use that are displayed electronically on the device, available on an electronic storage medium supplied with the devices, or available via a website. The manufacturer is responsible for preparing the electronic instructions for use. The information in the electronic instructions for use must be in Norwegian. The user should always have the opportunity to obtain the instructions for use in paper format. Information on the right to request this shall be provided in the information accompanying the device. For medical devices, the conditions for the use of electronic instructions for use are given in the Commission Regulation (EU) No. 207/2012. For IVD medical devices intended for professional use only, the instructions for use may be given in a format other than paper format, for example, electronically. This does not apply if the device is to be used for near-patient testing, cf. IVDR annex I, section 20.1 point f. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/language-requirements-and-information-following-the-medical-device
5. Software and Service Manual
The manufacturer must ensure that the software is in Norwegian and provides information on safe and secure use. There are no special software requirements. The service manual is usually not covered by the Norwegian language requirement. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/language-requirements-and-information-following-the-medical-device
6. Requirements for Labeling
The information on the labelling shall be impossible to delete, easy to read, and easily understood by the user of the device. Detailed requirements for the information in the labelling and instructions for use are stated in MDR Annex I (23) and IVDR Annex I (20). https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/language-requirements-and-information-following-the-medical-device
7. 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. The manufacturer of the implantable medical device must disclose the following information with the device: identification of the device (device name, serial number, lot number, UDI, device model, manufacturer’s name, address and website), necessary warnings/precautions (such as interference, external influences, environmental conditions), information about the expected lifetime of the device and any necessary follow-up, and any other information to ensure safe use of the device by the patient. The information shall be in Norwegian, it must be made quickly and easily accessible to the patient, and updates shall be available via the manufacturer's website. For certain implants, exceptions have been made from the requirement for implant cards and information provided to patients, see MDR Article 18 (3). https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/language-requirements-and-information-following-the-medical-device
8. Exemption from the Norwegian Language Requirement
It is possible to apply for an exemption from the language requirement, cf. regulation on medical devices § 15. Exemptions are not granted on a general basis, nor for an unlimited period of time. The exemption from the requirement for the Norwegian language is interpreted strictly and the manufacturer must submit an application to the Norwegian Medical Products Agency with the arguments for the exemption. If an economic operator applies on behalf of the manufacturer, the application must contain a power of attorney (PoA) from the manufacturer. NOMA will consider the need for the device, whether there is an alternative device on the market that fulfils the requirements, whether there is time to translate labeling/instructions for use into Norwegian language, whether the device will be used by professionals, and whether safe and correct use is ensured. Application form available via NoMA portal. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/language-requirements-and-information-following-the-medical-device
9. 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 Medical Products Agency, provide all information and documentation necessary to show that the device complies with the requirements in Norwegian or English, cf. the Regulation on medical devices § 12. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/language-requirements-and-information-following-the-medical-device
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