WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Special products and situations: clinical investigations, emergency use, combination products, companion diagnostics, software, reprocessing, refurbishing, donations, disposal and falsified devices – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 4.4.4-lot: Support NRA-required lot verification testing of high-risk (Class D) IVDs and control transport and storage so lot performance is not affected

What does 4.4.4-lot require?

Countries may run risk-based lot verification of Class D IVDs, before distribution, after distribution or before use, through a designated national reference or other competent laboratory, to confirm that each lot satisfies the requirements set for it on safety, quality and performance, and that shipping and storage have not affected performance. The need depends on the other controls in place, such as stringent transport and storage control and effective quality control in the receiving laboratory.

Maintained by Gerard Blokdyk

Other controls in Special products and situations: clinical investigations, emergency use, combination products, companion diagnostics, software, reprocessing, refurbishing, donations, disposal and falsified devices – WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices controls