Module 15 Presentations

10/04/2024

Lecture 5 The Summary of Safety and Clinical Performance

Rachel Gibbs

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

1

Agenda

• MDR Requirements • Guidance: MDCG 2019-9 • Healthcare Professional & Patient Sections of SSCP • Validation Process and the Notified Body • Maintenance of the SSCPs • Translations

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

2