Harmonized Standards for Medical Device

CE Certified Medical Device CE Marking manufactures should follow European standard from the European Commission (CEN, CENELEC or ETSI) to demonstarte compliance with Essential Requirments as per Medical Device Regulation (MDR). 

Those organization looking for CE Marking of Medical Device the first choice of standard is Harmonized Standards  ( Refer Here)

For more information refer here
In order to prove conformity of the manufactured device, manufacturer has to test the ready to use medical device using as per the requirments of latest harmonized standard

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