Module 16 2024

18/10/2024

Content

• MDR requirements supporting PSUR

• PSUR embedded in the PMS and CER

• Preparing a PSUR

• Creation of outputs and distribution of PSURs in the EU

• Further ramifications of PSURs once made available

• Summary

© NAMSA 2023 | 5

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MDR requirements supporting PSUR

© NAMSA 2023 | 6

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