Module 15 Presentations

10/04/2024

Implication of MDR 745/2017

The Organisation for Professionals in Regulatory Affairs

7

EU MDR 2017/745 The Regulation

Key objectives 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

8