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Norwegian register for devices and EUDAMED

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Changes

It is a legal requirement for Norwegian manufacturers, assemblers, and authorized representatives to register themselves and their equipment.

Registration contributes to the Norwegian Medical Products Agency's guidance for manufacturers, market surveillance, and the handling of reported incidents involving medical equipment.

Registration Requirements for Medical Device Stakeholders

The registration requirement does not apply to foreign manufacturers and authorized representatives who place equipment on the Norwegian market through a Norwegian importer or distributor. Distributors and importers also have no registration obligation.

Actor Norwegian register Eudamed
Norwegian Manufacturer Mandatory Voluntary
In-house Manufacturer Mandatory Eudamed not open for In-house manufacturers
Norwegian Authorised representative Mandatory Voluntary
Norwegian Importer No obligation Voluntary
Norwegian Distributer No obligation Eudamed not open for distributers
Foreign Manufacturer No obligation Voluntary
Foreign Authorised representative No obligation Voluntary
Foreign Importer No obligation Voluntary
Foreign Distributer No obligation Eudamed not open for distributers

Registration should be done in the national equipment register.

Eudamed is the new European database for medical devices, and its use is not mandatory yet.

Overview of the different roles of economic operators:

 

Table showing the definition in MDR and IVDR of different roles of an economic operator
Economic operator

Definition in M​DR 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.
*«Union» in this context means countries in the EU/EEA and​ Turkey.  
 
Figure: Economic operators in the supply chain.
 

Contact us

Unit for medical devices - market surveillance

(+47) 22 89 77 00

Medical device vigilance

msod@noma.no