Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Post Market Performance Follow-up (PMPF) plan

Plan for the proactive collection and evaluation of data to confirm post-market performance (and identify new risks) • Quality Assurance (external quality assurance, proficiency tests, ring trials) • Post-market performance study

The Organisation for Professionals in Regulatory Affairs

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Post Market Surveillance plan

Plan for the proactive collection and use of information on post-market surveillance : • Incidents, PSUR, FSCA • Trend reporting • Literature, databases • Market information • Similar medical devices

The Organisation for Professionals in Regulatory Affairs

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