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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.
 
#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.
 
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