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A useful PMCF plan starts with a residual clinical question, then selects a method capable of answering it.
PMCF plans — Define the regulatory scope
MDR Annex XIV Part B sets the PMCF framework. MDCG 2020-7 offers a planning template; completing its headings does not prove that a method is adequate.
PMCF plans — Build the working record
Create a gap-to-activity table linking residual risk, long-term performance or population uncertainty to method, endpoint, sample rationale and review date. Explain why a registry, survey or specific study can provide relevant evidence.
PMCF plans — Check before release
- Define the population and device variants.
- State measurable outcomes and acceptable completeness.
- Assign an escalation trigger for weak data.
PMCF plans — Record the decision and handover
Approve the plan with clinical evaluation and risk management owners. Record what finding would change the benefit-risk conclusion and how the resulting data will enter the evaluation report.
Frequently asked questions
- Is every customer survey adequate PMCF?
- No. Assess whether its design and data quality address the stated clinical question.
- Can PMCF be justified as unnecessary?
- Any justification must be device-specific and meet the applicable requirements; avoid a blanket waiver.