PMCF Study

What is a PMCF study?

A Post-Market Clinical Follow-Up (PMCF) study is an essential activity conducted by medical device manufacturers to assess the ongoing safety and effectiveness of their products once they are in use. This involves the systematic collection and evaluation of clinical data from real-world settings like hospitals and clinics. The main goal of a PMCF study is to provide evidence that the devices continue to perform as expected in everyday applications, ensuring they remain safe and effective throughout their lifespan.

These studies form a critical part of the post-market surveillance framework mandated by the European Union Medical Devices Regulation (EU MDR) 2017/745. Unlike pre-market clinical trials, PMCF studies are focused on long-term monitoring of the device’s performance, detecting new risks, side effects, and misuse patterns. The insights gained from PMCF activities are used to update clinical evaluations and ensure ongoing regulatory compliance, confirming that medical devices maintain their intended safety and efficacy over time.

When is PMCF required?

PMCF is necessary when additional real-world clinical data is required to substantiate the safety and performance of a device. This is particularly relevant for implants and new technologies, where ongoing data collection through PMCF is crucial for demonstrating their effectiveness in actual use.

According to the MDR, the post-market surveillance (PMS) system should be proportional to the device’s risk class and appropriate for its type. While high-risk devices almost always require PMCF, which should be updated at least annually, lower-risk devices and well-established technologies may not need it. However, manufacturers must provide a justification if they decide not to conduct PMCF for these devices. Most devices should have a PMCF plan, although not all will necessitate specific PMCF studies or methodologies.

Manufacturers are required to review the criteria set out in the European Commission regulation governing PMCF (MDDEV 2.12/2) to determine if their device needs a PMCF study. If a manufacturer concludes that PMCF is unnecessary, this rationale must be documented in the technical file. The primary factors driving the need for PMCF are the device’s risk level and novelty. High-risk and novel devices are more likely to require PMCF studies.

How to develop a PMCF plan？

To ensure success in a Post-Market Clinical Follow-Up (PMCF) study, a well-defined PMCF plan is essential. This plan should specify the chosen PMCF study method and how the findings will be documented in an assessment report. The selected endpoints must be appropriate to accurately assess the device’s safety and effectiveness, aiming to determine the correct benefit-to-risk ratio throughout its lifespan. The plan should clearly outline the data sources and the preferred methods for data collection, which should correspond to the risk level of the device.

Key elements of a PMCF plan include handling complaints, reviewing vigilance reports, conducting literature reviews, executing PMCF studies, collecting real-world evidence, surveying product use, addressing regulatory responses, analyzing returned products, and reviewing registries. Given that PMCF is a structured activity, it requires a detailed plan for gathering and evaluating data.

The Medical Device Coordination Group (MDCG) provides guidelines that suggest organizing the PMCF plan into seven sections:

1. Manufacturer’s Contact Information: Include the contact details of the manufacturer.
2. Device Description and Specifications: Provide a detailed description of the medical device under study.
3. PMCF Activities: Outline the general and specific methods and procedures to be used.
4. References to Technical Documentation: Cite relevant sections of the technical documentation.
5. Evaluation of Clinical Data: Review clinical data for similar or equivalent devices.
6. Relevant Standards and Guidance: Reference applicable common specifications, harmonized standards, or guidance documents.
7. Estimated Report Completion Date: Indicate when the PMCF evaluation report is expected to be finalized.

The PMCF evaluation report should mirror the structure of the PMCF plan, recording the results of the conducted activities and their implications for the technical documentation. The report should conclude with a summary of the findings and their connection to the initial PMCF plan.

What are PMCF activities?

Post-Market Clinical Follow-Up (PMCF) encompasses a range of methods for collecting clinical evidence, which should be tailored to the specific medical device. The EU Medical Devices Regulation (MDR) identifies two types of PMCF activities: general and specific. Manufacturers should select appropriate activities and justify their choices in the PMCF plan.

General PMCF Activities involve gathering clinical experience from healthcare professionals, collecting feedback from users and patients, reviewing scientific literature and published studies, and analyzing data from similar or equivalent devices. While these activities can provide useful insights, the data can often be subjective and may not be robust enough to fully confirm the device’s safety and performance.

Specific PMCF Activities offer more direct and rigorous data collection methods, including conducting PMCF studies, post-market interventional clinical investigations, evaluating third-party registry data, conducting investigator-initiated studies, and carrying out case series and cohort studies. These methods provide more reliable evidence but may be more demanding in terms of resources and effort.

According to the MDR, both general and specific methods must be used to collect clinical data. These methods need to be detailed in the PMCF plan, and the results should be documented in the PMCF evaluation report to ensure a thorough assessment of the device’s performance and safety.

Why PMCF is important?

PMCF is essential because it helps identify potential issues or risks over time, enabling manufacturers to take corrective actions. It ensures that devices perform as intended throughout their lifecycle. Each PMCF plan should detail specific activities for gathering data, as well as timelines and required resources. The methods for collecting data can include clinical studies, post-market surveillance, and analysis of real-world data, depending on the device’s risk level and intended use.

High-risk devices, such as implantable pacemakers, may require rigorous PMCF activities, including long-term studies. Lower-risk devices, like blood glucose monitors, might need only periodic surveillance. PMCF is an ongoing process integrated into the manufacturer’s quality management system, ensuring continuous monitoring and assessment.

Why Choose Us?

At Accel, we understand the importance of Post-Market Clinical Follow-Up (PMCF) studies in ensuring the ongoing safety and effectiveness of medical devices. Our team of experts is well-versed in the systematic collection and evaluation of clinical data from real-world settings, providing evidence that your devices continue to perform as expected in everyday applications.

Our service is comprehensive, covering all aspects of PMCF studies. From determining when a PMCF is required, to developing a robust PMCF plan, conducting PMCF activities, and understanding why PMCF is important, we have you covered. We tailor our methods to the specific medical device, ensuring a thorough assessment of the device’s performance and safety.

Choose us for our deep industry knowledge, our commitment to quality, and our unwavering dedication to our clients’ success. Let us help you maintain the intended safety and efficacy of your medical devices over time.

About Accel

Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.