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Post-market performance follow-up should test whether the evidence remains valid in actual populations, specimens and settings.
PMPF plans — Define the regulatory scope
IVDR Annex XIII Part B sets the PMPF framework. MDCG 2022-2 places follow-up within the continuing performance evaluation.
PMPF plans — Build the working record
Create a signal-to-question plan for population drift, interfering substances, rare specimens, user variation and changes in clinical practice. Select data sources with denominators and methods that can distinguish performance changes from reporting noise.
PMPF plans — Check before release
- Link each activity to a performance uncertainty.
- Define trigger thresholds and review frequency.
- Check coverage of intended users and specimens.
PMPF plans — Record the decision and handover
Approve responsibilities for data review and evaluation updates. When a signal appears, assess claims, risk controls and follow-up methods together rather than filing a complaint trend without a clinical conclusion.
Frequently asked questions
- Is PMPF identical to complaint collection?
- No. Complaint information may contribute, but follow-up must address the defined performance questions.
- Can an unchanged assay require new evidence?
- Yes. Users, pathogens, populations or clinical practice may change even when the assay does not.