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

1) For each device, the manufacturer shall establish, document, implement, maintain and update a post- market surveillance system… • Proportionate to the risk of the device • Appropriate for the type of device • Integral to the QMS

Fundamentally, the PMS processes will be the same for each device.

However, the level of monitoring may increase based on the device’s risk profile.

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

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

2) The post-market surveillance system shall be suited to actively and systematically gathering, recording and analyzing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.

PMS data must be actively and systematically collected.

Quality, performance and safety data must be collected.

The data must be recorded and analyzed to drive remediation/improvement (CAPA).

It must be collected for the entire lifecycle of the device.

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