Module 16 2024

17/10/2024

What are the post-market surveillance requirements of the MDR?

• Article 83, Post-market surveillance system of the manufacturer

3) Data gathered by the manufacturer's post-market surveillance system shall in particular be used:

c) to update the clinical evaluation;

Clinical evaluation sits at the heart of the risk management process.

It is the tool which gathers ALL performance and safety information.

It is the tool which determines the benefit/risk of a device.

PMS data is essential in supporting the manufacturers benefit/risk claims.

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What are the post-market surveillance requirements of the MDR?

• Article 83, Post-market surveillance system of the manufacturer

3) Data gathered by the manufacturer's post-market surveillance system shall in particular be used:

d) to update the summary of safety and clinical performance referred to in Article 32;

For Implantable and Class III devices relevant information from PMS/PMCF must be published in the SSCP.

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