WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices
Post-market obligations: adverse events, field safety corrective actions, withdrawals and post-market surveillance – 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 6.3.3.1-PMS: Operate post-market surveillance within the QMS that collects user feedback, reviews the benefit-risk profile, reports the required events, evaluates and takes corrective action, with importers and distributors keeping feedback records

What does 6.3.3.1-PMS require?

As part of the QMS, manufacturers should carry out post-market surveillance, including review of user feedback, to decide which adverse events and incidents to report and to review the benefit-risk profile of devices in use, implementing corrective actions to reduce recurrence. NRAs may review these systems in QMS audits, together with the manufacturer's investigation of feedback and implementation of corrective and preventive actions including field safety corrective actions; importers and distributors should keep records of user feedback, complaints and actions taken.

Maintained by Gerard Blokdyk

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