Date : 11-03-14 17:19
The definition of 'Clinical Data'
 Name : CE Manager
Hit : 407  
‘clinical data’ means the safety and/or
performance information that is generated from the use of a device. Clinical data are sourced from:
— clinical investigation(s) of the device concerned;
or
— clinical investigation(s) or other studies reported
in the scientific literature, of a similar device for
which equivalence to the device in question can be
demonstrated; or
— published and/or unpublished reports on other
clinical experience of either the device in question
or a similar device for which equivalence to the
device in question can be demonstrated;

refer to the MDD 2007/47/EC