Module 19: Regulation of In Vitro Diagnostic Medical Devices

18/04/2023

IVD performance characteristics

Analytical Performance

Analyte

Device

Scientific Validity

Clinical Performance

Clinical condition

State of the Art

The Organisation for Professionals in Regulatory Affairs

15

Companion Diagnostics

Medicines legislation

Marketing Authorisation

Phase I trial

Phase II/III trial

Devices Authority review/notification Medicines Authority review

Medicines Authority opinion Medicines Authority review

Notified Body review

Analytical performance/ Scientific validity

CE mark (Companion Diagnostic)

Clinical performance study

Devices Regulation

The Organisation for Professionals in Regulatory Affairs

Setting the Scene – EU Focus

16

8