Module 15 2022

19/05/2022

Identify the clinical data

MDR Annex XIV1(b): “identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic scientific literature review”

MEDDEV 2.7/1 section 8: ● Data generated and held by the manufacturer ● Data from the literature

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

23

Identify the clinical data

Data generated and held by the manufacturer: ● All Pre-market clinical investigations ● All Clinical data from risk management and PMS activities ● Relevant Pre-clinical data Data from the literature Data from literature: ● Clinical data on the device ● Clinical data on equivalent device(s) ● Clinical data to establish the current knowledge/state of the art

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

24

12