Module 15 2022

19/05/2022

Appraise the clinical data

Appraisal process for each document:

 Identify relevant information  Evaluate the methodological quality and the scientific validity  Determine the relevance of the information to the clinical evaluation  Systematically weight the contribution of that data set to the clinical evaluation

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

31

Appraise the clinical data

Some negative examples - data lacking validity MEDDEV 2.7/1 A6: Lack of information Numbers too small for statistical significance Improper collection of mortality and serious adverse event data Misinterpretation by the authors

MDCG-6 (legacy devices) Appendix III Hierarchy of types of clinical data

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

32

16