Module 15 2022

19/05/2022

MDR Requirements relating to SSCPs

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

3

Summary of Safety and Clinical Performance (SSCP)

What is it? • Summary document of the clinical evidence supporting the safety and performance of the medical device.

Who is it for?

Does not replace IFU or implant cards

• Healthcare Professionals. • Patients/Users.

Why?

• To drive transparency. • To ensure clinicians and patients have visibility to the level of clinical evidence used to support the device. • To ensure clinicians and patients are informed on safety and clinical performance.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

4

2