Medical Devices
What Is PMCF in Medical
Devices?
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Post-market clinical follow-up (PMCF) is one of the numerous post-market surveillance requirements outlined under the European Union Medical Device Regulation (EU MDR).
The purpose of a PMCF is to systematically and proactively collect clinical data on the use and outcomes of your medical device. All post-market surveillance (PMS) activities aim to confirm that the medical device is performing as intended and that any potential safety concerns are identified as quickly as possible. Ultimately, benefits of the medical device must always outweigh any prospective risks involved in its use.
An essential part of the post-market surveillance activities is a post-market clinical follow-up (PMCF). Today, we will explore objectives of a PMCF, the methods for conducting one, and how to create a PMCF plan for the future.
What Is PMCF?
A well executed post-market clinical follow-up (PMCF) encompasses activities that present data, documentation, and authentication about the safety and performance of a medical device. This report plays a crucial part in meeting the requirements for post-market surveillance of medical devices in Europe and elsewhere. The purpose of a PMCF is to validate a device’s clinical effectiveness and safety in practical applications.
Over the course of a device’s life cycle, risk determination may be revised by factoring in PMCF and PMS data gathered from actual usage of the device in the field.
After the product achieves its CE Mark, PMCF activities are required to be conducted, to enhance the existing data obtained during pre-market clinical and non-clinical evaluation of the device. Manufacturers must conduct a PMCF using statistical justifications based on patient populations, device usage, follow-up times, and results.
What Is the Purpose of PMCF?
Under the MDR, specific PMCF objectives are as follows:
- Identifying and assessing risks that remain after the device is used
- Assisting in updating clinical evaluation
- Identifying unexpected dangers and adverse effects
- Verifying the medical device’s safety and effectiveness throughout routine use
- Recognizing systemic misuse of the equipment and how it affects performance and safety
A PMCF plan should document the design of PMCF studies and surveys, and the outcomes must be summarized in a PMCF Report. The PMCF itself makes up a component of the Clinical Evaluation Report (CER) for the device.
A PMCF survey must be customized to the qualities, intended patient and user group, risk categorization, and intricacy of each device. Because of this, design knowledge of the clinical investigation is crucial to assuring the study’s purpose is met.
Structuring a Post-Market Clinical Follow-up Report and Plan
A PMCF cannot be carried out ad hoc. Manufacturers need to create a post-market clinical follow-up plan that outlines the process they plan to use to gather and evaluate clinical data related to the device.
The Medical Device Coordination Group (MDCG) has provided guidance on both the PMCF plan (MDCG 2020-7) and the PMCF report (MDCG 2020-8). In essence, the PMCF plan should include seven sections:
- The manufacturer’s contact information
- Overview and specification of the medical device under investigation
- The PMCF-related activities—both general and specific methods and procedures used
- Citations to relevant parts of the technical documentation
- A review of clinical data for equivalent or similar devices
- Citations to any relevant common specifications, harmonized standards, or guidance papers
- The expected date of the PMCF assessment report
The template layout for a PMCF assessment report is almost the same as the plans. This makes sense, as the report records the outcomes of the plan.
The report will adopt the same basic format, but will be sure to include the results of the activities performed and the effect of those results on device technical documentation. The report should conclude with documentation of the conclusion and its relation to the PMCF plan.
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What Is a Periodic Safety Update Report?
Moving forward, it’s important to understand what a periodic safety update report is. A PSUR is one of the two new reports on PMS that medical device producers must keep up with and routinely send to their Notified Body (NB). The PMCF report informs the CER, which informs the PSUR on a continuous evaluation of risk vs benefit of the medical device.
The periodic safety update report format is unique, but in essence, it is a summary of manufacturers’ post-market surveillance results and conclusions, including a description and rationale for corrective or preventive actions.
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