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 6.2.4.5-6.3.3.2-MS: NRA: conduct risk-based market surveillance using distribution-chain risk, user feedback and manufacturer surveillance data, with focused sampling and testing through collaborating laboratories

What does 6.2.4.5-6.3.3.2-MS require?

Market surveillance should be prioritised by risk, drawing on assessment of the distribution chain, user feedback and information from manufacturers' post-market surveillance, and can grow into a systematic risk-based plan using regulatory checks, analysis of investigation and audit data and targeted sampling and testing applied cost-effectively, ideally through national or regional laboratory collaboration.

Maintained by Gerard Blokdyk

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