Recent Activities - 2020
NRL to Develop Guidelines for the Design and Implementation of Post-Market Monitoring of Near Patient In-Vitro Diagnostic Devices
NRL is developing and finalizing guidance for end-users on how to conduct quality monitoring of in vitro diagnostics (IVDs) and to develop use cases for better supply of end-user quality control materials and proficiency testing panels. In association with the WHO Regulation and Safety (REG)/Incidents and Substandard/Falsified Medical Products (ISF) group, NRL will develop guidelines that will inform Global Fund and other procurers of near-patient testing IVDs on how to establish a quality assurance and post market framework.
Global Fund spends about 4 billion USD for the control of priority diseases HIV, malaria and TB. Much of the testing associated with these interventions are conducted in a community setting. NRL has identified that the traditional, laboratory-based quality assurance processes are not fit for purpose and their use in near patient testing is inappropriate. Working with WHO and Foundation for Innovative New Diagnostics (FIND), NRL heads this initiative. The aim is to develop an innovative approach to the delivery of quality assurance and post-market monitoring that is suited to testing in remote and regional locations which are geographically difficult to access. These novel guidelines will identify barriers in access to traditional quality assurance, determine methods for removing these barriers and establish new processes that can be universally applied, while acknowledging the need to have a practical and cost-effective process that conforms with established regulatory requirements of IVD manufacturers. This work is expected to be completed by November 2020.