Frequently Asked Questions

What is the purpose of MDR?

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Guidelines & Standards

The purpose of Medical Device Reporting (MDR) is that regulation requires medical device manufacturers, device user facilities, and importers to establish a system. The system must ensure the prompt identification, timely investigation, reporting, documentation, and filing of device-related death, serious injury, and malfunction information.

The events described in Medical Device Reports (MDRs) may require the FDA to initiate corrective actions to protect public health.