MDR system/procedurepack (article 22) with device acc. to MDD and MDR

#1
Hi,
my colleagues and me are currently discussing about article 22 of MDR. Is it possible to combine 2 devices that are approved by notified body acc. to MDD/MDR? An example: Device A is certified acc. to MDR and device B is certified acc. to MDD. Is it possible to declare a system/procdure pack acc. to article 22 of MDR for the mentioned combination?
In addition to the question above, another ambiguity raised: Can we use accessories that are certified according to MDD for a medical device that is certified acc. to MDR?
Thank you very much in advance for your support.
 
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#2
Hi Flansius,

In addition to the question above, another ambiguity raised: Can we use accessories that are certified according to MDD for a medical device that is certified acc. to MDR?
How is that possible? Your accessories are parts of the Declaration of Conformity of your device. Only the parts in de DoC could be used as a accessory for your medical device. So if the accessories are parts of your DoC according MDR, they are also MDR certificied.
 
#3
Thank you very much for your answer. I try to specify our situation:
We develope a new medical device according to MDR. The accessories used for this new device are part of another medical device from another company. This medical device is certified according to MDD (including the accessories). We want to use the accessories without any changes. The intended use remains the same. We do not want to be the legal manufactrer for the accessories. Can we do it according to article 22/MDR? Or is it only possible, if the accessories are certified as medical devices and not as accessories?
 
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