Module 16 2024

18/10/2024

What is the Periodic Safety Update Report (PSUR)?

• A summary of data from post-market surveillance (PMS) plan activities over a given time period

• Documents the current (at a given time) safety and performance of a device(s).

• Opportunity to compile information from PMS activities to ensure the benefit/risk is favourable.

• Not required for Class I devices – require PMS Report as per Article 85.

• For legacy devices* a PSUR is required during the transitional period

* Placed on the market under the MDD after 26 th May ‘21

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MDR requirements supporting PSUR

• Within the EU regulatory structure related to device safety, vigilance and post-market surveillance (PMS) has a unique place…

• Risks associated with medical devices necessitate a comprehensive monitoring system….. . all serious product incidents are required to be reported.

• The medical devices vigilance system applies to all incidents which might lead to, or might have led to, the death of a patient or a user, or to a serious deterioration in their state of health.

• Manufacturers are responsible for PMS. ……..required to actively survey the safety and performance of the devices they place on the market in the EU.

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