Refurbishment of Medical Devices

I

Imager

#1
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 If one component is now totally out of date can we replace that with the new component if it is seperately registered?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
 
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rob73

looking for answers
#2
Does this help??
http ://www. team-nb. org/Documents/R2_1-5_rev5.pdf - DEAD 404 LINK DECOUPLED
Rob
 
Last edited by a moderator:
I

Imager

#3
Many thanks for your reply

I've been reading that but slightly confused following reading the remanufacture of medical imaging devices report (remanufacturing.org.uk/pdf/story/1p89.pdf ) which states refurbishment puts the device back to its original state but remanufacture puts the device in a state that is better than when it was new so is a different device and must reapply for a CE marking.

thanks

Fran
 

Peter Selvey

Staff member
Super Moderator
#4
Looking at the question it appears that you are a manufacturer that is working with your own devices, and that you are using parts or software that has been used in newer "CE marked" devices.

From a legal point of view, this affects your declaration of conformity. Originally declarations were intended to the serial no. specific, but according to industry agreement, a declaration can be open ended using first date of manufacture or first serial number to define a starting point. Also according to normal industry practice, new declarations are not signed for every design change, i.e. the old declaration is considered effective. The legality of this I'm not sure but I have seen this as common practice.

So, from that side it seems to be no problem to upgrade parts or software in older systems.

But ... there is always a but ... it is not a given that such upgrades are backwards compatible, do not introduce problems, affect compliance with standards, need revised instruction or service manuals and so on. There should be some verification to consider these potential effects.

Of course, "verification" may take many forms, and may or may not involve actual testing, e.g. if engineering judgement says it is obvious that there are no problems. But, this decision at least needs to be recorded.

Provided records exist in the technical file to show backward compatibility, then upgrading to newer components should not require any special action. While it may be legally a new "placing on the market", the existing physical CE mark and declaration of conformity remain valid.
 
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