Language requirements and information following the medical device

Language requirements for medical devices

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, this 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)
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 § 15. 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 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. 

Below you will find information on what the application must contain.

Information about the device:

• Name of the device and risk class
• A description of intended use
• EU Declaration of Conformity
• EC-Certificate from notified body (for devices in higher risk class)
• A copy of labeling and instructions for use

Background for the application:

• Name of the user that will handle the device (hospital/clinician)
• A statement from the user explicitly stating that safe and correct use is ensured without Norwegian labeling and instructions for use
• Whether there are alternative devices meeting the requirement for Norwegian labeling and instructions for use available on the market
• Consequences for a patient/patient group if an exemption is not granted
• Specify the time period for which the application applies to
• A plan for translating labeling and instructions for use into Norwegian

Exemptions are not granted on a general basis, nor for an unlimited period of time​.

The application should be marked with “Application for exemption from the language requirement” and sent to meddev-no@noma.no​.

DMP will consider:

• The need for the device, including whether the situation of a particular patient/patient group indicates that an exemption should be granted
• Whether there is alternative device on the market that fulfil the requirements
• Whether there is time to translate labeling/instructions for use into Norwegian language
• Whether the device will be used by professionals
• Whether safe and correct use is ensured, including how the user ensures safe and correct use without Norwegian labeling and instructions for use

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 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​.

Labelling and instructions for use

The manufacturer shall ensure that the device is accompanied by information that identifies the device and the manufacturer. Information regarding safe and secure use, customised to the intended user of the equipment, shall also be provided.

​​​​​Detailed requirements for the information in the labelling and instructions for use are stated in MDR Annex I (23) and IVDR Annex I (20). ​

The information must be easy to read and understand by the intended user and impossible to remove. 

The information must be provided on the device itself. If this is not practicable or appropriate, some or all of the information may be provided on the packaging.

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. For more information on this, see the Electronic instructions for use.  

For implant cards and information supplied to patients with implanted devices, see more information under Implant card.

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 (see Labelling and instructions for use). 

The information in the electronic instructions for use must be in Norwegian, see the Language Requirement.

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.  

Medical Devices

The conditions for the use of electronic instructions for use for medical devices are given in the Commission Regulation (EU) No.207/2012​. For information, common specifications for the use of electronic instructions for use in accordance with the MDR are being worked on by the European Commission. 

IVD medical devices

For 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.  ​

Implant card and information given to patients with implants

​​An implant card is given to patients who have received a permanently implantable medical device or an active implantable medical device. Manufacturers of implantable devices are responsible for creating an implant card that contains information about the implanted device.

The purpose of implant cards is to enable the patient to identify the implanted device and access other information related to it as well as to inform healthcare professionals and others of the need for special treatment these patients may have in emergency situations.

For special implant card requirements and information to be supplied to patients with implants, see MDR Article 18. The manufacturer shall provide an implant card together with implantable medical devices. The card identifies the device and contains necessary warnings / precautions such as the expected lifetime of 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 that the patient or healthcare professionals must take into account for example

  • ​interference

  • external influences

  • environmental conditions

• information about the expected lifetime of the device and any necessary follow-up

• any other information to ensure safe use of the device by the patient

​The information must be made available to the patient rapidly and easily. Updates must be made available via the manufacturer's website. The information must be in Norwegian.

The Norwegian Medical Products Agency requests health institutions to give patients with implant cards rapid access to current information about their implanted medical device.

For certain implants, exceptions have been made from the implant card requirement and information provided to patients, see MDR article 18 (3).

For further information see Factsheet for Manufacturers of Implantable Medical Devices.