Writing the PMCF evaluation report
The post-market clinical follow-up (PMCF) evaluation report presents and evaluates the results of the activities a PMCF plan set out, states what they mean for the technical documentation and whether further activities are needed, and can be delayed when a PMCF study runs late.
What the report is
The PMCF evaluation report, also called the PMCF report, is a document provided for by the European Medical Devices Regulation (MDR) that reports on clinical data collected on a CE-marked device. Once a device is CE-marked, the manufacturer should analyse the PMCF activities according to the predefined PMCF plan and report the findings in the PMCF evaluation report. The PMCF plan describes the methods and procedures for collecting clinical data, and the PMCF report describes and evaluates the results.
The MDCG report template
In April 2020 the Medical Device Coordination Group (MDCG) endorsed a PMCF evaluation report template, alongside a PMCF plan template, to guide manufacturers in complying with the relevant requirements. MDCG 2020-8 gives the guidance on how to set up the PMCF evaluation report. The templates are not European Commission documents and are not legally binding. They were designed to simplify both the manufacturer's work in complying with all relevant standards and the data extraction done by notified bodies or competent authorities. Uncertainties exist about which PMCF information has to be documented under the MDR and how, so the templates provide a helpful tool to simplify and accelerate the work of manufacturers and notified bodies.
The PMCF evaluation report is very similar to the PMCF plan in content and section structure, but the report focuses on presenting and evaluating the results of PMCF and determining their impact on the technical documentation. The report shall be a stand-alone document. The template has seven sections:
- A. Manufacturer contact details, equivalent to those in the PMCF plan.
- B. Medical device description and specification, equivalent to that in the PMCF plan.
- C. Activities undertaken related to PMCF: results. The section should describe the results of the PMCF activities as an analysis of the findings, has to describe the quality of the data, and should mention whether the findings may affect the technical documentation.
- D. Evaluation of clinical data relating to equivalent or similar devices, if applicable. The section should include a statement on whether the analysis of the findings and the conclusions may affect the benefit-risk ratio of the device.
- E. Impact of the results on the technical documentation. The section should state that impact, so the report gives it twice, here and in section C.
- F. Reference to any common specifications, harmonised standards or guidance documents applied.
- G. Conclusions.
The penultimate section shall also reference the relevant parts of the clinical evaluation report and of the risk management, and any relevant common specifications, harmonised standards and guidance on PMCF, if applicable.
Critical analysis of the results
The report has to provide a critical analysis of the collected data, which means evaluating the quality of the data, discussing favourable and unfavourable results, discussing the results as part of the next clinical evaluation report and concluding whether further activities are currently required. Insufficient detail in PMCF plans and reports is a common pitfall.
The conclusion
The last section of the report should draw an overall conclusion of the findings and relate it to the aims of PMCF, state the impact on the clinical evaluation report or the risk management documentation, and, importantly, state whether further activities are needed, such as a corrective and preventive action or perhaps an extended follow-up where a clinical study was conducted. The conclusion focuses on any corrective and preventive actions that need to be implemented. It should also consider whether the current clinical evaluation, the risk management documentation, the post-market surveillance plan or, if applicable, the summary of safety and clinical performance need updating.
Causes of a late report
A PMCF report can be late for many reasons. Getting ethical approval for a PMCF study can be quite time-consuming. In one practitioner's experience, there is still a lack of understanding of the need for PMCF activities and studies under the new regulations. Ethics committees are sometimes quite difficult to convince of a PMCF study's design and of the number of patients it is to include. Where different devices are usually all used in one intervention, it is suitable to try to address them all in one study, and the same practitioner thinks many manufacturers try to do so. An ethics committee, however, might question the feasibility of addressing more than one device in one study, and ethics committees sometimes request very high sample sizes for such a study.
A wrongly chosen study design is another reason a PMCF report may not be produced in due time. PMCF studies have to comply with ISO 14155, but the study hypothesis and endpoints also have to be thought through to be sure that the study yields scientifically sound conclusions. Where many hospitals postpone their interventions, patient recruitment times may also be underestimated.