| Regulatory information regarding medical devices | https://legemiddelverket.no/english/medical-devices/regulatory-information-regarding-medical-devices | Regulatory information regarding medical devices | About medical devices, the legislation, the Norwegian Medicines Agency's role and derogation from the conformity assessment procedure. | 1579 | About medical devices, the legislation, the Norwegian Medicines Agency's role and derogation from the conformity assessment procedure. |
| How to place a medical device on the market | https://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market | How to place a medical device on the market | A guide to the regulations and procedures that must be followed when placing a medical device on the market. | 3471 | A guide to the regulations and procedures that must be followed when placing a medical device on the market. |
| Clinical investigation of medical devices | https://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-device | Clinical investigation of medical devices | Before 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). | 1581 | Information 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-devices | Performance 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. | 3571 | Information regarding application and notification, safety reporting, substantial modifications and ending or temporary halt of a study. |
| Requirements and responsibilities regarding medical devices on the market | https://legemiddelverket.no/english/medical-devices/requirements-and-responsibilities-regarding-medical-devices-on-the-market | Requirements and responsibilities regarding medical devices on the market | Information on how manufacturers, importers, distributors and authorized representatives has to follow up on medical devices on the market in Norway. | 3487 | Information 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 devices | https://legemiddelverket.no/english/medical-devices/reporting-of-serious-incidents-involving-medical-devices | Reporting of serious incidents involving medical devices | Incidents 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-devices | Glossary – Medical devices | | 1587 | |
