IVD Post-Market Performance Follow-Up (PMPF)

For IVDs, the equivalent of PMCF is Post-Market Performance Follow-Up (PMPF), which involves the proactive collection of post-market performance data to confirm the IVD's analytical and clinical performance in routine use.

PMPF is required for Class III and IV IVDs and should include:

• Monitoring of ongoing laboratory proficiency testing data;
• Review of published literature on the IVD or equivalent devices;
• Active follow-up with key clinical laboratory users; and
• Periodic reanalysis of clinical performance data from the registration dossier against real-world performance.

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Official sources

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