EU MDR deliverable
What PMCF is for
Post-Market Clinical Follow-up is how a manufacturer keeps proving, after the device is on the market, what the Clinical Evaluation Report concluded before it. Annex XIV Part B requires a PMCF plan and a PMCF evaluation report, and the two together close the loop between the clinical evidence you had at certification and the evidence reality supplies afterwards.
The trigger for meaningful PMCF is almost always a gap named in the CER: a claim supported by short follow-up, a population under-represented in the literature, a rare complication the data could not quantify, or a residual risk accepted on the basis of assumptions. PMCF is the mechanism for closing those gaps with real data.
What we produce
- PMCF plan — the specific objectives drawn from the CER gaps, the methods chosen to address each one, the endpoints, the sample size reasoning and the timetable. Generic plans that say only “we will monitor literature and complaints” are rejected, because they answer no stated question.
- Method selection — PMCF survey of users or patients, registry participation, a post-market clinical investigation, structured review of the published literature, or analysis of real-world data from your own installed base. Chosen against the question, not by convenience.
- Survey and registry instruments, where those are the chosen route, including the data protection position for the personal data involved.
- PMCF evaluation report — what the data showed, whether it closed the gap, and what it changes in the benefit-risk determination.
- Feed-back into the CER, the risk management file and the PSUR, which is the part most often left undone and the part a notified body checks first.
- A PMCF justification where PMCF is genuinely not applicable, which is permitted but must be argued, not assumed.
Where PMCF goes wrong
- The plan is not derived from the CER. If the objectives in the PMCF plan cannot be traced to a named gap, the reviewer concludes the clinical evaluation never identified its own limitations.
- Data is collected and never evaluated. Surveys returned, registry entries made, and no PMCF evaluation report written. Collection without evaluation is worse than no plan at all, because it evidences a process that was not followed.
- Timing that misses the PSUR. For Class IIa and above the PSUR must summarise PMCF findings. If the evaluation report lands after the PSUR, the PSUR is incomplete.
- Response rates too low to conclude anything. Plan the sample and the follow-up mechanism realistically, and state in the plan what will happen if the target is not met.
How the work runs
We read the CER first and list every gap, assumption and unsupported claim in it. That list becomes the PMCF objectives. For each objective we propose the least burdensome method that can actually answer it, with a sample size and a timetable that fits your PSUR cycle. Once data is flowing we write the evaluation report and push the conclusions back into the CER, the risk file and the PSUR so the documents agree with each other.
Frequently asked questions
Is PMCF mandatory for every device?
A PMCF plan is required as part of the post-market surveillance plan for all devices. Where PMCF is not appropriate, the plan must contain a justification for that conclusion. Silence is not an option; a reasoned exemption is.
Does a literature review count as PMCF?
It can form part of it, but rarely alone for anything above Class I. Literature tells you about devices in general; PMCF is expected to tell you about yours.
How often must PMCF data be evaluated?
On the frequency set in your plan, aligned to the PSUR cycle: annually for Class IIb and III, at least every two years for Class IIa.
Can PMCF replace a pre-market clinical investigation?
No. PMCF confirms and extends evidence that was already sufficient for certification. It cannot substitute for evidence that was missing at the point of conformity assessment.
Who owns PMCF in the organisation?
It sits with the person responsible for regulatory compliance under Article 15, drawing on clinical, quality and post-market surveillance functions.
PMCF forms part of the technical documentation maintained for CE marking, and we can run it as an ongoing engagement alongside your ISO 13485 quality system.