To comply with the Post-Market Clinical Follow-up (PMCF) requirements laid out in EU MDR, MedTech companies must proactively collect clinical data on their products throughout the entire device lifecycle.
And while these requirements have been in writing since MDR was first published in 2017, many companies with devices in Europe are still hesitant to perform proactive PMCF activities as the regulation requires. In a lot of cases, this is because management views PMCF activities only as a cost. The general attitude is that these activities don’t produce anything—they’re just something that has to be done to satisfy the regulations.
However, this is a case where attitude shapes reality. Companies that treat PMCF as a check-box activity probably won’t get much out of it. But there are enormous opportunities waiting for companies that are willing to take PMCF activities seriously and integrate them into the lifecycle management of their device.
Here’s what you need to know about turning PMCF into a competitive advantage for your business.
How does PMCF fit into device lifecycle management?
The medical device lifecycle progresses through four stages: introduction, growth, maturity, and decommission.
Prior to MDR, there was a lot of fragmented data collection during the device lifecycle, which inevitably led to a fragmented understanding of the device. Companies typically leaned into the reactive forms of post-market surveillance, like vigilance and complaints. Now, however, MDR mandates that companies perform more proactive activities, such as PMCF studies, to help create a balance between reactive and proactive data collection.
Integrating PMCF into your device lifecycle means collecting data on your device when it is first introduced and then continuing to collect data through the device’s lifecycle, from growth and maturity to decommission. Companies that pursue meaningful PMCF activities throughout the device lifecycle will create a compliant and consistent process for obtaining performance and safety data on their devices, as well as ensuring their risk management files stay up to date.
Those companies will also accumulate real-world evidence on their device—how it’s being used in clinical settings by users and/or patients. And that accumulation of data can have big impacts on the way a company does business, leading to design updates and even entirely new products.
How can companies use their PMCF as a competitive advantage?
The first step in productively using your PMCF as a competitive advantage is to identify the lifecycle stage of your device: introduction, growth, maturity, or decommission.
This is an important step because the stage your device is in may help determine the PMCF activities you perform—or whether you do them at all. In some cases, if a device is at the end of its lifecycle, it could make more sense to decommission it in Europe rather than undertake extensive PMCF activities.
In most cases, however, companies will want to keep their device on the market, which means undertaking PMCF activities. Though not every company will need a PMCF study, the data from such a study can help you do a number of things:
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Prove claims about safety and effectiveness.
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Understand how users are interacting with the device under real-world circumstances.
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Identify off-label use, including any safety concerns and necessary updates to risk management.
However, all the real-world data you collect from your PMCF activities can then be used to create a new device—sometimes multiple devices. For instance, you might identify off-label use of your current device that exposes unmet user needs a new device can satisfy.
This isn’t a hypothetical scenario, either. In our free webinar on PMCF as part of the device lifecycle, Efstathios Vassiliadis, CEO of Evnia, shares an example of a company that was initially reluctant to undertake a PMCF study. However, the data they obtained from the study led to four new devices—none of which had competitors on the market.
Why do companies tend to avoid proactive PMCF activities?
One of the biggest reasons companies struggle with PMCF is that upper management often doesn’t understand the opportunities it holds. They may listen to what the regulatory team says, but what they hear is that PMCF is the cost of doing business—it’s something to get done quickly and with minimum expense.
The reality is that you need management’s support if you want to pursue more meaningful PMCF activities. And to gain that support, you need to speak to them in a language they understand. That probably means dialing back the use of regulatory language and speaking to the opportunities for business development that PMCF holds. Because if management only sees the costs, and not the opportunity, they will probably tell you “no.”
Connect PMCF to the lifecycle of your device, and the development of new devices, and you have a better chance at getting approval for the PMCF activities you need.
No matter what PMCF activities you choose, Greenlight Guru can help
There are many different types of PMCF activities, from clinical investigations to literature reviews and surveys, but whatever you choose, you need to be able to collect and manage your clinical data in a secure and compliant manner.
We built Greenlight Guru Clinical to be your single, compliant platform for collecting and managing all your clinical evidence, safety, and performance data. Whether you’re setting up a PMCF study or sending post-market surveys, you’ll have everything you need to easily and securely obtain the data you need.
Our eClinical platform comes optimized for medical device studies—meaning you have built-in compliance with EU MDR, ISO 14155:2020, and FDA requirements. There’s no coding and no stressful setup. Instead, Greenlight Guru Clinical offers straightforward GCP-compliant reporting and customizable forms to fit the needs of any study, with flexible access and permissions, safeguarded data management for informed consent and electronic records, real-time event progress tracking, data export, and more.
Ready to see how Greenlight Guru Clinical can simplify your PMCF? Then get your free demo of our software→
Checklist for a more efficient clinical study setup
