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Compatibility between MDD and MDR devices

A

Asia78

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#1
#1
I am being wondering if a new MDR product can declare compatibility to an existing mdd product... (The mdd product will not change)
What do you think? Any reason why it shouldn't be possible? Thanks
 
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Watchcat

Watchcat

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#2
#2
Do you mean equivalence, such as would be needed if you want to use data from the one device in the clinical evaluation of the other?
 
A

Asia78

Involved In Discussions
#3
#3
Hi watchcat, no, I mean that we have two separate devices, each with their own DoC, which can be used together being that compatibility has been tested.
Only problem is that one will stay under MDD, the other one will be under MDR.
Any concerns? Thanks
 
Watchcat

Watchcat

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#4
#4
Ah, that makes sense. I'm hoping someone here can answer your question off the top of their head, because I really hate trying to figure out anything involving multiple devices at one time. Usually makes my brain hurt. :confused: Off the top of my head, though, I can't think of any reason this should be a problem.
 
jkuil

jkuil

Quite Involved in Discussions
#5
#5
There is no requirement in the MDR that devices that are claimed to be compatible with the medical device that is being assessed shall be CE marked under MDR. Such a requirement would cause that a medical device can only be CE marked under MDR when all compatible devices are CE marked under MDR. This is impossible for a manufacturer to assure and would require the manufacturer to constantly update the IFU once new devices that may be used with the medical device are being CE marked.
 
A

Asia78

Involved In Discussions
#6
#6
Thanks for the confirmation, I see it in the same way.

Different is a MDD device that wants to declare compatibility to a MDR device. In this case the MDD device will have a "significant change" and will need to be also MDR compliant.
 
dgrainger

dgrainger

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#7
#7
Don't you still need to show that your MDD device is compatible with the MDR device? This will be a change to Essential requirement 9.1 and a significant change.
 
A

Asia78

Involved In Discussions
#8
#8
Well, this is exactly the point. If the device is already on the market and released under MDD, I guess you can declare compatibility only on one direction: MDR device compatible to the existing MDD one. Without any change in the MDD product.

Or is the compatibility necessary in both directions? I don't see a reason
Thanks
 
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