Post Market Clinical Follow up (PMCF) Plan/Report

What is a Post Market Clinical Follow-Up Plan?

The Post Market Clinical Follow-Up (PMCF) plan – or Post Market Performance Follow-Up (PMPF) plan for in-vitro diagnostic devices – is a regulatory document that describes how you (the manufacturer) plan to proactively collect and evaluate data from the clinical use of a medical device after putting the product on the market. The European Medical Device Regulation 2017/745 (MDR) considers PMCF to be a continuous process that updates the clinical evaluation. The PMCF plan shall be part of the Post Market Surveillance (PMS) plan.

The aim of the PMCF plan is to:

confirm the safety and performance of your device throughout its expected lifetime
identify/monitor side-effects
identify and analyse emergent risks
ensure the continued acceptability of the benefit-risk ratio
identify possible systematic misuse or off-label use of your device, with a view to verifying that the intended purpose is correct.

In order to support the objectives above, the PMCF plan should describe the various activities that will be carried out to gather post-market clinical data. Sources for such activities may e.g., include device registries, clinical investigations, real world evidence and surveys.

What is a PMCF survey?

A survey is a research activity that collects clinical data from e.g., users or patients through the use of a questionnaire. As a medical device manufacturer, you can use the survey to collect PMCF data for your CE-marked device. Compared to most other PMCF activities, surveys can be considered more simple, fast and cost-effective. As surveys can be designed to avoid the collection of traceable data or personal data on the patients, there is typically no requirement for involvement of the ethics committee or competent authority. The questionnaires can be sent to the recipients as a document that may be filled out by hand or using an electronic data capture system (e.g., SurveyMonkey or SurveyXact). The latter eases the data analysis and is a “must have” when the questionnaire is sent to many recipients.

According to the MDCG 2020-6 guidance, surveys can either be considered rank 4 evidence or rank 8 evidence, depending on the quality of the survey. Class III legacy devices and implantable legacy devices must have sufficient clinical data of rank 4 or above (except for well-established technologies). Through AML Christensen’s consulting services, we can help you determine whether your device needs a survey of rank 4 or rank 8. Moreover, we can design a survey that fits your needs and helps close the clinical gaps for your device.

Rank	Data source
1	High quality clinical investigation
2	High quality clinical investigation with some gaps
3	High quality clinical data collection systems (e.g., registries)
4	Studies with potential methodological flaws (e.g., high quality surveys)
5	Equivalence data
6	Evaluation of the state of the art (e.g., clinical data from similar devices)
7	Vigilance databases
8	Proactive Post Market Surveillance (e.g., surveys)
9	Case studies
10	Non-clinical studies related to common specifications
11	Simulated use / animal / cadaveric testing involving healthcare professionals
12	Pre-clinical and bench testing

Reach out

What is a Post Market Clinical Follow-Up (PMCF) evaluation report?

The findings from the activities in the PMCF plan shall be analysed, and the results of those analyses are documented in a PMCF evaluation report (or PMPF evaluation report for in-vitro diagnostic devices). The conclusions of the PMCF evaluation report are then taken into account when updating the Clinical Evaluation Report, Risk Management Files, Post Market Surveillance (PMS) Plan and the Summary of Safety and Clinical Performance.

AML Christensen’s service

At AML Christensen, we have a long-lasting experience in developing PMCF plans/reports that comply with the requirements of the EU MDR and relevant guidelines. At AML Christensen, we can create the first PMCF plan/report for your device and ensure that the plan is regularly updated throughout the device’s lifetime. In addition, we can develop a PMCF questionnaire that enables you to collect survey data for your device. Similarly, we can generate and update the PMPF plan, report and survey for your in-vitro diagnostic medical device.

At AML Christensen, we have a proven PMCF plan template, which is based on the MDCG 2020-7 guidance. In addition, we have a PMCF report template that is based on MDCG 2020-8. Both have been developed to ensure that the requirements of the MDR are met. Your PMCF plan/report may be built using the AML templates or we can use your own templates, if you prefer.