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.