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Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
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- Understanding post-market surveillance requirements for medical devices (US & EU markets)
- Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
- Biomarkers as drug development tools: discovery, validation, qualification and use
- Clinical Biomarkers in Drug Discovery and Development
- Non-Inferiority Clinical Trials to Establish Effectiveness
- FDA Approval Process
- Three tools that help medical device SMBs work remotely
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Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
[/vc_column_text][vc_column_text]Post-market surveillance is a collection of actions carried out by manufacturers to gather and analyze experience obtained from medical devices that have been placed on the market and determine the need for any action. Post-market surveillance is an important tool for ensuring that medical devices remain safe and effective and that steps are done if the chance of continuing to use the medical device outweighs the benefit. Post-market surveillance experiences can also be used to identify possibilities to enhance the medical device.
- The WHO Global Model Regulatory Framework for Medical Devices mandates medical device post-market surveillance. This comprises national regulatory agencies (NRAs) responding to reports of adverse incidents, often known as vigilance. The terms “adverse event” and “incident” may be used interchangeably in various jurisdictions. The term incident will refer to a variety of experiences that may be acquired when using a medical device.
- As a result, the words post-market surveillance, vigilance, and market monitoring are all intertwined. Users’ experiences with medical equipment are reported to the makers. Certain occurrences are reported to NRAs, and they are kept up to date on the measures taken. The NRA will conduct an assessment of the manufacturers’ inquiry and subsequent measures. This is related to NRAs’ market surveillance obligations. Market surveillance refers to the complete package of operations performed by NRAs to gain supervision of medical devices on the market in their area and to guarantee that the safety, quality, and performance of medical devices on the market remain consistent.
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References
World Health Organization. “Guidance for post-market surveillance and market surveillance of medical devices, including in-vitro diagnostics.” (2020).[/vc_column_text][/vc_column][/vc_row]
