Module 16 2024

17/10/2024

The post market surveillance plan

1) Post-market surveillance processes:

The PMS plan shall cover…

Annex III, 1.1(b), Indent 1 - A proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterization of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;

PMS procedure – describes the systematic processes for reactive/pro-active PMS

Clinical evaluation procedure – describes how similar device data is analyzed/utilized

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The post market surveillance plan

2) Post-market data assessment processes:

The PMS plan shall cover…

Annex III, 1.1(b), Indent 2 - effective and appropriate methods and processes to assess the collected data;

PMS procedure – describes the appropriate methods to assess PMS data

Clinical evaluation procedure – describes how post-market clinical data is assessed

Risk management procedure – describes the risk evaluation processes

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