Parts and components that change performance or intended purpose

Obligations and responsibilities

Obligations and responsibilities that economic operators assume when repairing and reprocessing a medical device that is defective or has impaired performance due to use: 

• ​They must ensure that the safety characteristics, performance or intended purpose of the device does not change

• They must ensure that the actions are carried out in accordance with the manufacturer's guidelines

• They must document that the safety characteristics, performance and intended purpose of the device have not changed 

In cases where a new part or component changes the performance, safety characteristics or intended purpose of the device, it is considered a medical device and shall meet the requirements of a medical device.  

In cases where repairs are made to a device intended for single use, this measure is regarded as reprocessing and entails full manufacturer responsibility. In Norway reprocessing of single-use medical devices are not permitted (prohibition from 1 January 2022).

The regulation distinguishes between repair and fully refurbishing of medical devices. 

Fully refurbishing means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation. Fully refurbishing results in the assignment of a new lifetime to the refurbished device. Note that fully refurbishing entails full manufacturer responsibility. 

Supporting documentation must be available to the Norwegian Medical Products Agency as the competent authority. 

For a complete overview, see MDR Article 23 and IVDR Article 20.

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.