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About medical deviceshttps://legemiddelverket.no/english/medical-devices/about-medical-devicesAbout medical devicesThe Norwegian Medicines Agency's role regarding medical devices and the legislation. 1578The Norwegian Medicines Agency's role regarding medical devices and the legislation.
How to place a medical device on the markethttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-marketHow to place a medical device on the marketA guide to the regulations and procedures that must be followed when placing a medical device on the market.3471A guide to the regulations and procedures that must be followed when placing a medical device on the market.
Clinical investigation of medical deviceshttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-deviceClinical investigation of medical devicesBefore starting a clinical investigation of a medical device, the sponsor must determine if the investigation is subject to application, notification or neither to the Norwegian Medicines Agency (NoMA). ​​​1581Information regarding the process, NoMAs application processing, including amendments and termination of the investigation.​
Performance studies of in vitro-diagnostic medical devices (IVDs)https://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/performance-studies-of-in-vitro-diagnostic-medical-devicesPerformance studies of in vitro-diagnostic medical devices (IVDs)A performance study is carried out to establish the analytical or clinical performance of an IVD. IVDR lists requirements for performance studies to ensure valid, reliable and robust generated data, and that the participaters rights are protected.3571Information regarding application and notification, safety reporting, substantial modifications and ending or temporary halt of a study.
The Norwegian legislationhttps://legemiddelverket.no/english/medical-devices/regulatory-information-regarding-medical-devices/the-norwegian-legislationThe Norwegian legislationInformation about the Norwegian legislation on medical devices.3095Information about the Norwegian legislation on medical devices.
Regulatory information regarding medical deviceshttps://legemiddelverket.no/english/medical-devices/regulatory-information-regarding-medical-devicesRegulatory information regarding medical devicesMedical devices - Register. Clinical investigation. Classification. Placing on the market. Free sales certificate. Notified body. Administrative and advisory responsibilities related to legislation for medical devices. 1579
Norwegian language requirementshttps://legemiddelverket.no/english/medical-devices/norwegian-language-requirementsNorwegian language requirementsAccording to current legislation labeling and information supplied by the manufacturer shall be in Norwegian.2260
Requirements and responsibilities regarding medical devices on the markethttps://legemiddelverket.no/english/medical-devices/requirements-and-responsibilities-regarding-medical-devices-on-the-marketRequirements and responsibilities regarding medical devices on the marketInformation on how manufacturers, importers, distributors and authorized representatives has to follow up on medical devices on the market in Norway.3487Information on how manufacturers, importers, distributors and authorized representatives has to follow up on medical devices on the market in Norway.
Reporting of serious incidents involving medical deviceshttps://legemiddelverket.no/english/medical-devices/reporting-of-adverse-incidents-involving-medical-devicesReporting of serious incidents involving medical devicesIncidents with medical devices on the market, as well as injuries, accidents and failures where medical devices is or may have been involved, shall be reported to the Norwegian Medicines Agency. 1586
Glossary – Medical devices https://legemiddelverket.no/english/medical-devices/glossary-–-medical-devicesGlossary – Medical devices 1587

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