Guidance and regulations
Published:
Changes
The Norwegian Medical Products Agency is the competent authority for medical devices in Norway. The Agency has administrative and advisory responsibilities related to legislation and supervisory authority over economic operators and notified bodies.
Norway has the same rights and obligations as other EU Member States with regard to requirements for medical devices and the EEA Agreement.
A medical device is a device intended by its manufacturer to be used specifically to diagnose, prevent, monitor, treat or alleviate disease, injury or disability in humans. Some birth control products, as well as tools for the handicapped people are also considered as medical devices. For the full English definition see MDR article 2.
An in vitro diagnostic (IVD) medical device is a device intended for the analysis of samples from the human body for medical purposes, see IVDR article 2.
A product that achieves primary effect through pharmacological, immunological or metabolic action is not considered as a medical device – this type of product is regulated by the Regulations on medicinal products.
Medical devices shall comply with the essential requirements given in the regulations and directives before the device can be CE marked (see also Notified Body), as a confirmation that regulatory requirements aremet. The way to CE marking depends on the risk classification of the device.
Information on regulatory requirements for clinical investigation of medical devices can be found under Clinical investigation.
Manufacturers/authorised representatives of medical devices have a responsibility for internal control (risk analysis, conformity assessment procedures). Medical devices that are CE marked in one EU/EEA country can freely be placed on the market in all EU/EEA countries.
The Norwegian Medical Products Agency may upon request issue time-limited Free Sales Certificate for Norwegian manufacturers of medical devices to be exported to countries outside the EU/EEA.
As a part of the market surveillance all Norwegian manufacturers/authorised representatives of medical devices shall register in the Medical Device Database (Utstyrsregisteret). The Norwegian Medical Products Agency is responsible for the Norwegian medical device vigilance system.