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 8.1-disposal: Give users decontamination and disposal instructions, and dispose of devices at end of life (or earlier if hazardous) safely in line with manufacturer recommendations and local rules

What does 8.1-disposal require?

Once a device reaches end of life, or sooner if it can no longer perform safely, must be disposed of so it is not reused and causes no harm to people or the environment, following local rules and what the manufacturer recommends, with particular care for sharps, infectious, hazardous, toxic, radiological, electronic or human-derived material. Labelling or e-labelling should explain proper decontamination and disposal; for complex equipment, users and manufacturers should consult on the best route, and the NRA should set replacement and decommissioning criteria and a procedure for destroying falsified products.

Maintained by Gerard Blokdyk

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