A PMCF plan is the part of a manufacturer’s post-market surveillance (PMS) plan that specifies how it will proactively collect and evaluate clinical data on a CE-marked medical device. Annex XIV Part B of the EU MDR sets out the requirements, and the findings are reported in the PMCF evaluation report.
That report, structured under MDCG 2020-8, becomes part of the clinical evaluation report and the technical documentation. The plan says what you will do; the report records what you found. The Notified Body assesses both whether the plan is adequate and how it is applied.
For a broader introduction to the topic, read our guide to what PMCF is under the MDR.
A PMCF plan aims to confirm the safety and performance of a CE-marked device, including clinical benefit where applicable, throughout its expected lifetime. Beyond that confirmation, it is designed to surface unknown side effects, emergent risks and misuse, and to check that the benefit-risk ratio stays acceptable.
In practice, a PMCF plan is built to:
A PMCF plan that follows MDCG 2020-7 contains seven sections, A to G: manufacturer details, device description, PMCF activities, references to the technical documentation, equivalent or similar devices, applicable standards and guidance, and the estimated date of the PMCF evaluation report. Section C, the planned activities, is the core.
Each section is covered below, in template order.
Section A records who is responsible for the device. It holds the legal manufacturer’s name, address and SRN, the person responsible for regulatory compliance, and the authorized representative where applicable.
Section B describes the device: its general description, intended purpose, intended users and patient population, indications and contraindications. Any variants, configurations and accessories covered by the plan are listed here, together with the certificate number, the device class and the applicable classification rule.
Section C is the core of the plan. It describes every activity the manufacturer will carry out after market entry, whether it is a general method or a specific one. For each activity, state its aim, the rationale for why the chosen method is appropriate to reach that aim, the known limitations (such as incomplete follow-up or missing data), and the timeline. MDCG 2020-7 expects timelines to be defined quarterly, or at least yearly.
The template names a device registry, PMCF studies, real-world evidence analyses and surveys among the possible activities. We support the specific ones through our PMCF studies and surveys. For implantable and class III devices where clinical investigations were not performed pursuant to Article 61(4) of the MDR, the plan has to include post-market studies to confirm safety and performance.
Section D connects the plan to the rest of the file. The manufacturer references the information in the clinical evaluation report and the risk management file that needs further analysis and monitoring, or states that no relevant information applies.
Section E lists the equivalent or similar devices whose clinical data will be further evaluated and presented in the PMCF report. Data that demonstrates continuing safety and performance should come from your own device. Data from equivalent or similar devices plays a supporting role, for example to update the state of the art or to assess relevant safety outcomes.
For each device listed, indicate whether equivalence is demonstrated or the device is only similar, and point to where its clinical data is evaluated in the clinical evaluation report (date, version and location). The selection of devices must stay consistent throughout the technical documentation.
Section F lists any applicable common specification, harmonized standard or guidance document on PMCF, each with its title, date and version.
Section G states when the manufacturer plans to deliver the first PMCF evaluation report. As in Section C, the timeline is defined quarterly or at least yearly.
The common PMCF plan pitfalls are relying on general activities only, justifying the chosen methods weakly, collecting data that does not match the device’s claims, and promising more activities than the manufacturer can complete. The Notified Body assesses whether a PMCF plan is adequate, so each of these weakens it. Our article on the top five reasons PMCF plans fail under the MDR goes deeper on the same theme.
Only general activities. Manufacturers are expected to collect data from both general and specific activities, depending on the device. A manufacturer that chooses not to perform specific activities must provide a sound justification. A well-designed survey is one example of a specific activity; our tips for a high-quality PMCF survey show what that involves.
Weak justification. Each PMCF activity should be justified by the needs of the device. When the clinical data has large gaps, for example, a literature study may not be sufficient to address them. MDCG 2020-7 also asks for justification of sample size, timescales, endpoints and comparator, and it states that a retrospective survey without a statistical rationale is not acceptable.
Inconsistency between data and claims. The data you collect on the device should align with its claims and intended purpose. A mismatch between the two produces unusable data and wasted effort.
Overpromising. Committing to many activities may satisfy the Notified Body at first. The manufacturer is then expected to complete every activity it chose, which can mean higher costs and longer timelines than planned.
Qserve’s clinical team supports manufacturers with PMCF plans under the EU MDR, from auditing an existing plan to justifying the choice between general and specific PMCF methods and setting realistic timelines. If your plan is heading to a Notified Body, or your clinical evaluation needs updating, contact the team.