WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Manufacturer obligations: essential principles, technical documentation, clinical evidence, QMS, declaration of conformity, labelling and promotion – 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 4.4.3-IVD: For IVDs, establish clinical evidence covering scientific validity, analytical performance and clinical performance, with performance studies on human specimens to ISO 20916

What does 4.4.3-IVD require?

An IVD's clinical evidence comprises scientific validity, analytical performance and clinical performance data supporting its intended use, kept in the technical documentation with the risk management file (plan, assessment and report), verification and validation records, labelling and manufacturing information. Because much of this comes from studies on specimens taken from people rather than use on patients, ISO 14155 does not suit IVDs, and performance studies should follow ISO 20916:2019.

Maintained by Gerard Blokdyk

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