WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 4.3-changes: Keep changes to intended purpose, design, specifications, labelling or manufacture in conformity with the essential principles, classify changes as substantial or not under a procedure, and seek further evaluation where required

What does 4.3-changes require?

The manufacturer must make sure that any change after first placing on the market to the device's intended purpose, design, specifications, labelling or manufacture still meets the essential principles. It should keep and use a procedure that sorts and records changes to the device design or type (software included) and to the QMS as substantial or not substantial. Substantial changes are those that could reasonably affect safety, performance or conformity, such as changes to manufacturing process, facility or equipment, quality control or sterility methods, design, operating principle, materials, energy source, software or accessories, intended use, contraindications or the basis for the expiry period; depending on class these may need further NRA evaluation before implementation.