Module 15 2022

19/05/2022

Clinical Evaluation – Appraise the clinical data

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

29

Appraise the clinical data

MDR Annex XIV1(c): “appraise all relevant clinical data by evaluating their suitability for establishing the safety and performance of the device”

MEDDEV 2.7/1 section 9: ● Pre-defined appraisal plan ● Use full text ● Document the appraisal

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

30

15