Module 15 2022

19/05/2022

Lecture 6: The relationship between clinical evaluation and post-market surveillance (PMS)

Paul Risborough

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

1

Agenda

• Re-cap of the clinical evaluation process • MDR PMS requirements • PMS and PMCF data sources • The PMCF plan • Periodic Safety Update Report • Notified Body expectations

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

2

1