The Medical Devices Introductory Course 2020

Appraisal of clinical data Example 1

The Organisation for Professionals in Regulatory Affairs

Appraisal of clinical data Example 2

Criteria

Grading

Actual device

D01 D02 D03 I01 I02 I03 P01 P02

Same or similar device

Equivalent device

Other device

Same indication Minor difference Major difference Same population Similar population

Same indication

Same subject population

Different population

P03

The Organisation for Professionals in Regulatory Affairs