WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Recommendations to NRAs: pre-market, market and post-market oversight, pathways and implementation – 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 6.3.3.5-testing: NRA: avoid routine testing, use accredited laboratories (ISO/IEC 17025, ISO 15189) under defined agreements or reliance for targeted testing of falsified, incident-related, priority or lot-verification samples

What does 6.3.3.5-testing require?

Routine testing of devices by the NRA wastes scarce resources; manufacturers carry primary responsibility for testing under their QMS. Testing directed by the NRA should target suspected falsified devices, devices involved in adverse events, devices sent in by lay persons, planned post-market testing of priority devices, post-shipment IVD lot verification and law enforcement support, using national control or reference laboratories or competent outsourced laboratories with defined governance and a memorandum of understanding, accredited to ISO/IEC 17025 or ISO 15189 for the analytes concerned and verified by the NRA, operating a QMS with validated methods and controlled sample and record management; countries without such laboratories should rely on others.

Maintained by Gerard Blokdyk

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