Procedure pack EU

#1
Hi, I want to combine a non CE sterile medical device with a CE sterile medical device*currently MDD for a procedure pack. I will do the sterilisation. what do indeed to submit for the review to NB. will NB ask me to convert my MDD cert of the device to MDR now itself . what kind fo certificate does NB provide for procedure park, its not CE but what does it contain .
kindly advice .
 
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#2
Hi Raje,

You have mentioned a "non-sterile CE medical device with a CE sterile medical device"

A Sterile Medical Device must have a CE Mark due to the sterility aspect.
 
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