PMCF plans and reports that close the loop the CER opened
Part of our Post-Market Surveillance services, from a clinician led team serving India, MENA, Europe, and global markets.
Post-market clinical follow-up is where a device's clinical evaluation stops being a snapshot and becomes a system. EU MDR Annex XIV Part B requires a PMCF plan that proactively collects clinical data on the device in real use, and a PMCF evaluation report that feeds the findings back into the clinical evaluation, the risk management file, and for the highest classes the SSCP. Notified bodies read the PMCF plan against the CER's gap analysis, and the fastest way to a finding is a generic plan that could belong to any device in the catalogue.
EvySaif writes PMCF plans and evaluation reports aligned to the MDCG template structure, with the methods chosen for the specific residual questions your clinical evaluation report actually identified. Because the same clinician led team writes the CER, the PMCF documents, and the SSCP, the loop closes by construction rather than by later reconciliation.
Building a PMCF plan that survives review
- Questions from the gap analysis. Long term performance, rare complications, use in subpopulations underrepresented premarket, off label use signals: each residual uncertainty from the clinical evaluation becomes a named PMCF question with an owner.
- Methods proportionate to the question. Registries, investigator or user surveys, focused PMCF studies, and structured literature surveillance each answer different questions at different costs; the plan matches method to question and justifies the choice.
- Real endpoints and timelines. Sample size logic, data sources, analysis approach, and reporting milestones stated concretely enough that the evaluation report can later be judged against them.
- The feedback loop. The PMCF evaluation report states what was found, what it changes in the benefit-risk profile, and which documents update as a result, which is precisely what reviewers look for and what generic reports omit.
Where this connects
PMCF sits inside the wider post-market surveillance system, alongside the PMS plan, PSUR or PMS report, trend reporting, and vigilance, covered by our post-market surveillance services, and its IVD counterpart, post-market performance follow-up, within our IVD performance evaluation work.
Frequently asked questions
Is PMCF mandatory for every device under EU MDR?
PMCF is the default expectation, and any decision not to conduct it must be justified in the PMS plan. For implantables and Class III devices, meaningful PMCF is effectively unavoidable, and its results feed the SSCP and periodic reports.
What is the difference between the PMCF plan and the PMCF evaluation report?
The plan (MDR Annex XIV Part B) specifies the questions, methods, and milestones in advance; the evaluation report presents the findings and their consequences for the clinical evaluation and risk management. Notified bodies read them as a pair.
Can PMCF rely on literature and registries instead of new studies?
Often, where those sources genuinely answer the residual questions. The justification lies in matching the method to the question; general market surveillance alone is not PMCF, which is a common nonconformity we help manufacturers correct.