Module 16 2022

9/2/2022

Challenges selecting inputs for PSUR • Important when selecting inputs for the PMS report / PSUR: o All aspects of Annex III need to be addressed: no justification possible to exclude or consider a requirement non applicable: at least, means there are the minimum defined requirements to address. o Many devices may have different (physical) characteristics and intended purposes: how to make sure you prevent comparing apples with pears. o Process, methods, protocols and tools all need to work effectively. o Process and documentation needs to be maintained in order to continue to meet with the MDR and market information tends to change over time. o This means that this process requires process validation with input from multiple stakeholders: Risk Management, Clinical, Quality Management, Regulatory Affairs and Senior Management.

MDR

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© NAMSA 2021

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PMS outputs and distributing PSURs in the EU

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© NAMSA 2021

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