WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Recommendations to governments and NRAs: legal basis, NRA set-up, resources, reliance and the stepwise controls – 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 6.2.2.6-exceptions: Government and NRA: define exemptions and enforcement discretion for emergencies, humanitarian use, individual patients, clinical investigations, exhibitions and donations, with risk-benefit evaluation and clear guidance

What does 6.2.2.6-exceptions require?

Some requirements may justifiably be waived during public health emergencies, or for a single patient in exceptional cases, but should let the NRA weigh risks and benefits and authorize the specific deviation. The law should set out defined exemptions and enforcement discretion, for example for humanitarian use, emergencies, clinical investigations, exhibitions and donated devices, communicated clearly with guidance.

Maintained by Gerard Blokdyk

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