Glossary

Fully refurbishing [MDR/IVDR]

MDR IVDR

‘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.

 

[Definition under (EU) 2017/745 Article 2 No. 31 also corresponds to definition under (EU) 2017/746 Article 2 No. 24]