Module 15 2022

19/05/2022

Analyse the clinical data

MDR Annex XIV1(e): “analyse all relevant clinical data in order to reach conclusions about the safety and clinical performance of the device including its clinical benefits.” MEDDEV 2.7/1 section 10: ● use sound methods ● make a comprehensive analysis ● determine if additional clinical investigations or other measures are necessary ● determine PMCF needs

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

37

The Clinical Evaluation Report

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

38

19