R
reg123
I would like to know if somebody has experience with NB current thinking regarding the qualification of the clinical evaluation reviewer. According to MEDDEV 2.7.1 Rev 4 it should be qualified person with specific requirements defined. While it is not refer to in-dependency - I am not sure if internal reviewer or internal team is accepted as it is requested to provide conflict of interest statement and in most of the case any internal reviewer has conflict of interest. Nevertheless not sure it is realistic that just external individuals will conduct it. Thoughts ? Thanks