Labeling requirements for REFURBISHED medical devices

G

GGaelle

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#1
Hi RA folks,

Does anybody know what are the Labeling requirements in Europe for refurbished medical devices (NOT fully refurbished or remanufactured)? Does it need to be disclosed on the product label, DoC, etc...? It seems like the MDR does not have specific requirements for refurbished devices.

Thanks!
Gaëlle
 
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