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. From 1 January 2022, reprocessing of single-use medical devices are not permitted. 

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 Medicines Agency as the competent authority. 

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

Publisert: 07.04.2022

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