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 6.2.1.1-6.2.1.2-NRA: NRA: adopt a harmonized risk classification scheme with guidance and a voluntary classification consultation, require declarations of conformity with the essential principles, and recognise standards for presumption of conformity

What does 6.2.1.1-6.2.1.2-NRA require?

The law should include a classification scheme based on harmonized guidance and let the NRA issue guidance and implementing acts; the NRA should offer manufacturers a voluntary consultation on proposed classifications. It should make it a basic rule that, before entering the market, every device is shown to be safe, to work as intended and to be of good quality, require a declaration and timely evidence of conformity with the essential principles, enforce against missing or false declarations, and allow formal recognition of standards; recognition is best done through updateable guidance rather than legislation, preferring ISO, IEC and other international standards, keeping national adoptions current and setting transition periods for new editions.

Maintained by Gerard Blokdyk

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