What Is a PMCF Study?
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As a manufacturer of medical devices, you’re required to follow the established laws in the industry and ensure that your devices remain safe and effective throughout their lifespans. According to the European Union Medical Devices Regulation (EU) 2017/745, every manufacturer of medical devices must carry out periodic post-market clinical follow-up (PMCF) evaluations and collect and submit well-structured post-market surveillance reports regularly.
This follow-up study goes along with the periodic safety update report (PSUR) that you must submit either annually or after every two years, depending on the class of your medical device. Ensure you know the correct periodic safety update report format to avoid unnecessary trouble with the regulators.
In order to carry out your PMCF studies successfully, you have to understand what it is, how to perform it, and why it’s important. For instance, you need to understand that a PMCF study isn’t the same as a clinical investigation. So, how is a PMCF study different from a clinical investigation? This and other concerns you may have about a PMCF will be addressed in this article.
PMCF Studies Explained
A post-market clinical follow-up study is the practice of following up with clinics, hospitals, and other medical facilities on the safety and efficacy of your medical device. Through this study, you’re able to collect and document evidence to show that your medical devices are safe. This study is part of the larger post-market surveillance plan for medical devices.
The main objective of PMCF is to proactively remain informed about the clinical performance, effectiveness, and safety of your devices in real-world applications. Continuous command of this information is vital for helping manufacturers manage tolerable risk. The data is then fed back into re-evaluation and determination of risk throughout the lifecycle of the device.
This study is also part of the Medical Device Directive (MDD) 93/42/EWG. One of the MDD post-market surveillance requirements is that every medical device manufacturer must update their clinical evaluation information with evidence gathered during periodic post-market surveillance. You must also implement your PMCF study with statistical rationale in patient numbers, follow-up period, criteria, and usage of the device.
Unlike the PSUR, the PMCF study doesn’t have a prescribed format. Various options are permissible, including systematically curated evidence available in the literature, official clinical studies, and surveys to collect responses from medical professionals and patients. Sometimes, you might find the regulatory guidance inexplicable, which is why you should partner with the right PMCF solution for assistance. Further guidance from industry leading groups such as the Medical Device Coordination Group (MDCG) can assist with these efforts. For example, MDCG 2020-08, is a great overview of best practices for PMCF related activities.
How to Develop a PMCF Plan
To succeed in your PMCF study, you need to have a clear, well-structured PMCF plan that outlines the entire process. Define your preferred PMCF study method and style of documenting your findings in an assessment report.
The endpoints you select for your plan must be fitting so that you can effectively measure the safety and efficacy of your device. The main objective of a PMCF study is to establish the right benefit-to-risk profile of your medical devices all through their expected lifespans. Basically, your PMCF study plan should define the source of your data and the method you prefer to use to collect that data.
The data collection method you use should be proportional to the device risk. Some of the main components of your PMCF plan might include complaints handling, vigilance reports, literature review, PMCF studies, real world evidence and surveys about product use, regulatory response, return product analysis, registry review, and PMCF method and procedure.
Why PMCF Study Is Necessary
As discussed above, the PMCF study is part of the EU MDR and MDD, which require every medical device manufacturer to continuously follow up on their devices to ensure that they remain safe and effective in their clinical application throughout their life cycles.
Although medical industry regulators don’t need you to carry out a PMCF study for every device you create, you have to include your rationale in your technical documentation to show why you believe your device doesn’t need one.
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Risk and originality are the main reasons why a PMCF study is necessary. Original medical devices in the high-risk category need a PMCF study; otherwise, you risk losing your CE certification. The purpose of this follow-up study is to ensure that your devices are safe and effective.