Fully refurbishing

Under the MDR and IVDR, whoever fully refurbishes a device and places it on the market under their own name becomes its manufacturer. Ordinary servicing and repair do not count as full refurbishing.

‘fully refurbishing’, for the purposes of the definition of manufacturer, 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, combined with the assignment of a new lifetime to the refurbished device;

EU MDR, Article 2(31)

‘fully refurbishing’, for the purposes of the definition of manufacturer, 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, combined with the assignment of a new lifetime to the refurbished device;

IVDR, Article 2(24)