Module 16 2022

05/09/2022

PSUR in context of PMS

The Organisation for Professionals in Regulatory Affairs

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 Established in Article 86 of the MDR, required for technical documentation in Annex III  Required by manufacturers of class IIa, class IIb, and class III devices  Summarizes the results and conclusions of PMS activities  Contains the following:  Conclusions of the benefit-risk analysis  Main findings of the PMCF  Volume of sales of the device and size estimates of use population and usage frequency

The Organisation for Professionals in Regulatory Affairs

26