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Hi
I was hoping to find some help... We produce imaging machines and are trying to understand the rules on re-processing/re-manufacture. If we “refurbish” do we have to put the machine back to the state when it was first introduced even if there has been improvements in components/software since? Or, is it in line with the CE mark so if it is in a form still covered by the original CE mark (including if any substantial changes have been notified) that is ok. If we make it “as new” but up to date do we then need to re-register? If one component is now totally out of date can we replace that with the new component if it is seperately registered?
Sorry if it is not clear
Thanks in anticipation
I was hoping to find some help... We produce imaging machines and are trying to understand the rules on re-processing/re-manufacture. If we “refurbish” do we have to put the machine back to the state when it was first introduced even if there has been improvements in components/software since? Or, is it in line with the CE mark so if it is in a form still covered by the original CE mark (including if any substantial changes have been notified) that is ok. If we make it “as new” but up to date do we then need to re-register? If one component is now totally out of date can we replace that with the new component if it is seperately registered?
Sorry if it is not clear
Thanks in anticipation