The Medical Devices Introductory Course 2020

Primary Guideline for Clinical Evaluations

Preceded MDR by 11 months

The Organisation for Professionals in Regulatory Affairs

MEDDEV 2.7/1 rev. 4: Background

• EU Notified Bodies are commercial organisations, designated by their national Competent Authorities to assess whether manufacturers and their medical devices meet the requirements set out in legislation • Rev 3 published in December 2009 • CERs of poor quality continued • Competent Authorities dissatisfied with the quality of clinical data being provided to support the essential requirements for safety and performance • Notable scandals in the press

The Organisation for Professionals in Regulatory Affairs