Module 14 2022

21/03/2022

Aim of a clinical investigation

• Aim of a good clinical investigation is to provide objective evaluation of the safety and performance of the device in question, based on its intended purpose.

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

9

Determine statistical requirements

• Which standards are applicable?

• UK Medical Devices Regulations 2002 (UK MDR 2002)

• (EU) Regulations for Medical Devices 2017/745 (MDR)

• ISO 14155:2020: Clinical investigation of medical devices for human subjects - Good clinical practice

• ICH-E9 Statistical principles for clinical trials

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

10

5