WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 8.6-CDx: For companion diagnostics, obtain authorization for clinical performance studies and market entry, label the corresponding medicine where the test is tied to it, and report test failures to the device regulator (and medicine impacts to the medicine regulator)

What does 8.6-CDx require?

Companion diagnostics are IVDs that a medicine depends on for safe and effective use, normally Class C. They need NRA authorization for their clinical performance studies and for market entry, plus audits and post-market surveillance. Where a CDx is developed with a specific medicine, a combined clinical study is run and its labelling should name that medicine; standalone CDx are studied independently. Reportable events from CDx failure, such as inaccurate results, go to the device regulator, and if the failure could affect the medicine's safety or effectiveness the medicine's manufacturer should also report to the medicine regulator.