Legal framework for medical devices in Norway

The Norwegian legislation is harmonized with the EU regulations in this area, consisting of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This means that the legal framework for medical devices in Norway is essentially the same as that in EU countries.

Requirements for the production and documentation of medical devices

The manufacturing and packaging of medical devices must be carried out in such a way that, under normal use, they perform as indicated by the manufacturer and are compatible with a high level of protection for life, safety, and health. It is also required that the device's performance aligns with what is stated by the manufacturer. For the device to be marketed, it must be CE marked and accompanied by a declaration of conformity.

However, the MDR and IVDR allow the authorities in member states to adapt the regulations to national conditions by establishing their own national rules. In Norway, such supplementary rules have been provided in the form of language requirements and requirements for clinical testing. These are outlined in the Medical Devices Regulation sections 6-16 and can be summarized as follows:

• Information on the label and in the user manual of the device must be provided in Norwegian.
• Documentation used in conformity assessment procedures, including technical documentation, as well as audit, assessment, and inspection reports, must be provided in English.
• Information in the Declaration of Conformity must be in English or Norwegian.
• Certificates issued by notified bodies established in Norway must be in English or a language accepted by the notified body.
• The manufacturer and authorized representative must, upon request from the Norwegian Medical Products Agency (NOMA), present all information and documentation necessary to demonstrate that the device complies with the requirements in Norwegian or English.
• Information in the application for the designation of a notified body and the documents assessed during inspections must be provided in English.
• Safety messages from manufacturers to users of the device must be provided in Norwegian. The safety message may, in special cases, be provided in English until a Norwegian translation is available, but the Norwegian translation must be provided without undue delay.
• Information given to patients with implantable devices, which is to be accompanied by an implant card, must be provided in Norwegian.
• The general summary of the clinical trial must be provided in both Norwegian and English.
• Clinical trials must meet the requirements of Regulation (EU) 2017/745 (MDR) Article 62. This also applies to clinical trials that are not conducted for the purposes specified in Article 62(1) of the regulation.

The Norwegian Medical Products Agency (NOMA) is the supervisory authority for medical devices and supervises market participants and notified bodies.

For more information on the regulations for medical devices, click here.