Registration of medical devices
Norwegian manufacturers and Norwegian authorised representatives must register in the Norwegian Register for Medical Devices. Distributors and importers of medical devices are not obligated to register.
The Norwegian Register for Medical Devices
Norwegian manufacturers and authorised representatives are obliged to register their Medical device in the Norwegian Register for Medical Devices.
Registration should be performed at the start time of the placing on the marked of the medical device. A declaration of conformity should therefore be issued before registration takes place.
Manufacturers and authorised representatives localised in other Member States cannot register in the Norwegian Register for Medical Devices. Distributors and importers are not obligated to register.
How to register
To register in the Norwegian Register for Medical Devices for the first time, the manufacturer or authorised representative must fill out a form. The contact person will then receive username and password by e-mail. The form is only available in Norwegian. If you are unable to use the form, please contact NoMA at MSOD@legemiddelverket.no.
If you are already registered, please log in with your username and password.
Overview of the different roles of economic operators:
Definition in MDR Article 2 and IVDR Article 2
|Manufacturer||A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.|
|Authorised representative||Any natural or legal person established within the Union* who has received and accepted a written mandate from a manufacturer, located outside the Union*, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.|
|Importer||Any natural or legal person established within the Union* that places a device from a third country on the Union* market.|
|Distributor||Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.|
|Health institution||An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.|