The Medical Devices Introductory Course 2020

Clinical Evaluation – what it is and why is it needed PROCESS OVERVIEW

The Organisation for Professionals in Regulatory Affairs

What is clinical evaluation? MDR:

”A systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits , of the device when used as intended by the manufacturer”

New for MDR

Article 2 (44)

The Organisation for Professionals in Regulatory Affairs