Reducing duplication in Clinical Performance Studies

Clinical evidence for IVD medical devices consists of scientific validity, analytical performance and clinicalperformance.Premarket registration of IVD Medical Devices classed as high risk, where an incorrect result can endanger individual or public health, requires evidence that the probable benefits of using the test outweigh the risks. Manufacturers are required to supply evidence from prospective studies to establish clinical performance and  and operational characteristics of the device. If a device is to be used at the point of care (POC) then the study must be performed at the point of care.

Clinical studies are expensive and may take years to plan and execute. Currently there is large scale duplication of studies in Africa with some devices delayed market entry in some countries for years. Costs to the manufacturer are substantial and are a disincentive to registering products in small countries where financial returns are limited.

To reduce unnecessary costs and delays there should be mutual recognition of clinical evidence generated by studies undertaken in accredited laboratories/clinics when using approved protocols. Joint review of data should be undertaken.

PAHWP shall undertake a pilot project using new POC tests for people living with HIV  (CD4, viral load and early infant diagnosis)

©2016 Pan African Harmonisation Working Party
Improving Access to Affordable Diagnostics