Fully refurbishing

For the purposes of the definition of manufacturer, 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, combined with the assignment of a new lifetime to the refurbished device.

Reference: MDR Article 2(31); IVDR Article 2(24)

Previous
Previous

Field safety notice

Next
Next

Gap assessment