Module 16 2024

10/17/2024

MDR Post-Market Surveillance – A Product Life Cycle Approach

7

Source: https://www.metecon.de/en/leistungen/clinical-affairs/pms/

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

35

35

Overview of MDR PMS Reporting Requirements

Source: Modified Infographic derived from www.metecon.de/de/news/pms-und-pmcf-zur-gewinnung-klinischer-daten-bis-2020/u/1009/

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

36

36

18