Module 15 2022

20/05/2022

EU MDR 2017/745 The Regulation

Key objective of the revision

Protect The Health and Safety of patients Tighter Notified Body Controls Consistent, transparent Conformity Assessment

Greater emphasis on clinical data and clinical evaluations Post Market Surveillance and Post-Market Clinical Performance

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

9

Clinical Investigations MDR – Chapter VI

Clinical investigations Articles 62 to 82 ● Article 62: General requirements regarding clinical investigations conducted to demonstrate conformity of devices ● Article 74 (1): Clinical investigations regarding devices bearing the CE marking - within the scope of its intended purpose, additional procedures are invasive or burdensome ● Article 74 (2): Clinical investigations regarding devices bearing the CE marking - outside the scope of its intended purpose ● Article 82: Requirements regarding other clinical investigations – bearing CE-mark, no additional interventions (observational)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

10

5