Detailed requirements for the information in the labelling and instructions for use are stated in MDR Annex I (23) and IVDR Annex I (20).
Devices sold in Norway must have Norwegian labelling and instructions for use (see Language Requirements).
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.
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.