The Medical Devices Introductory Course 2020

Scoping and planning the clinical evaluation

MEDDEV states that before undertaking a clinical evaluation, the scope should be determined by the manufacturer • It should be based on the Essential Requirements (ERs) / General Safety and Performance Requirements (GSPRs) that need to be addressed from a clinical perspective and the nature and history of the device • The scope serves as a basis for further steps in the clinical evaluation process including identifying relevant data and highlighting any significant gaps or issues at an early stage

The Organisation for Professionals in Regulatory Affairs

MDR – CEP minimum contents

The Organisation for Professionals in Regulatory Affairs