Module 16 2024

18/10/2024

Preparing a 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 need to work effectively.

o Process and documentation needs to be maintained in order to continue to meet with the MDR and market information.

o Process requires validation with input from multiple stakeholders: Risk Management, Clinical, Quality Management, Regulatory Affairs and Senior Management.

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What Next? - PMS outputs and distributing PSURs in the EU

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