Module 16 2022

9/2/2022

Introduction • MDR requirements supporting PSUR • PSUR embedded in the PMS and CER • Challenges when selecting inputs for the PSUR • Creation of outputs and distribution of PSURs in the EU • Further ramifications of PSURs once made available • Closure

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© NAMSA 2021

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MDR requirements supporting PSUR • Within the EU regulatory structure related to product safety, the medical device vigilance system and PMS has a unique place… • Risks posed by medical devices necessitate a comprehensive monitoring system whereby 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. • Post Market Surveillance is a responsibility of the manufacturer that is required to actively survey the safety and performance of the devices on the EU community market.

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© NAMSA 2021

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