Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04

R

reg123

#1
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
 
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pkost

Trusted Information Resource
#2
The conflict of interest statement is for transparency. There is no restriction of internal employees writing the evaluation; they just have to conduct the evaluation fairly and impartially.

The main requirement is competence and the expectations are quite clear in the MEDDEV:
1. Can the person demonstrate they ability to critically review the literature...e.g. do they have an applicable degree
2. Do they know the subject area? e.g. have they worked in the field for a period of time? have they studied the area extensively at uni?

You can have multiple authors where their specialisms combine to give the reuqired competence.

It is entirely reasonable to use external resource to write a clinical review: consider a doctor/university researcher/med dev consultant etc etc
 
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