How Is a PMCF Study Different
From a Clinical Investigation?
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As a medical device manufacturer, you are required to adhere to the rules and regulations governing the industry. One of these regulations is the European Union Medical Device Regulation (EU 2017/745 or MDR), which requires every medical device manufacturer to conduct regular post-market activities and surveillance to ensure that their devices remain safe and effective throughout their expected lifespans.
One of these activities is the post-market clinical follow-up (PMCF) study. But what is a PMCF study, and is it the same as a clinical investigation? While both the PMCF study and clinical investigation involve gathering information about the safety and effectiveness of a medical device, they’re different in several ways.
What Is a PMCF Study?
A PMCF study, outlined in Annex XIV Part B of the MDR, is a follow-up investigation of your medical device once it has been released into the market to establish its safety and effectiveness. This study helps you to gather additional information about the device once it has been approved to be in the European market and is being used actively.
This study is one of the key EU MDR post-market surveillance requirements that you must comply with or you risk losing your Conformité Européenne (CE) certification. The CE mark indicates that your devices have been thoroughly assessed and deemed to satisfy EU safety, environmental, and health safety standards. This certification is required for any product manufactured in any part of the world and sold in the EU.
The PMCF study is a key factor that determines the ability of your medical device to be successfully compliant with EU market regulations. Therefore, you must learn when and how to conduct the study so that your devices can remain EU MDR compliant. As you familiarize yourself with the PMCF study, it’s also important to understand how to write a periodic safety update report (PSUR) for your medical devices, as well.
The PSUR and PMCF reports work together because they prove the safety and efficacy of medical devices that are already in use. For instance, a PMCF study helps you to identify potential outstanding risks of your medical devices that already have a CE certification mark, as well as to gather the information that will establish the long-term clinical effectiveness of the devices.
You need this study to confirm the clinical performance and safety of a new device that’s CE-certified. If your medical device or labeling has undergone significant changes and your Notified Body (NB) accepts the changes without ordering a pre-CE-marking investigation, you can just proceed to carry out a PMCF study.
This study also becomes necessary when the risk classification of your medical device increases significantly, or when post-market surveillance studies raise serious questions about the safety, clinical effectiveness, and performance of your medical device. At minimum, the PMCF demonstrates a continual, proactive commitment by a device manufacturer to upload post market surveillance requirements in good faith.
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What Is a Clinical Investigation?
A clinical investigation, outlined in Chapter VI (Articles 62-82) and Annex XV of Regulation (EU) 2017/745, is an inquiry into the safety and clinical performance and effectiveness of a medical device. This investigation is a component of the EU MDR, which requires all medical devices manufactured anywhere in the world and sold in the EU market to be continuously examined by their manufacturers for safety and effectiveness throughout their expected lifespans.
Article 2 of the MDR defines clinical investigation as “a systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a medical device.” A clinical investigation is done for conformity purposes, post-market clinical follow-up (PMCF) research involving invasive and burdensome procedures, and other clinical studies that aren’t done for purposes of conformity or PMCF.
Although the PMCF study and clinical investigation are done to protect subjects and ensure compliance with the medical device’s ethical standards, they don’t follow the same procedure. For instance, a PMCF study is conducted on medical devices that are already CE-certified. In contrast, a clinical investigation involves medical devices that aren’t yet CE-certified for the envisioned objectives used in the study.
In a clinical investigation, the study is done before the NB can CE-mark your medical device for its intended purpose. This ensures that the device meets the standard requirements under the EU MDR before it’s CE-marked. Lastly, despite the procedural difference between a PMCF study and a clinical investigation, the two studies require high moral standards and full protection of the subjects.
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