How to Carry Out PMCF Activities According to EU MDR

Post-Market Clinical Follow-up (PMCF) is a crucial part of the post-market surveillance requirements outlined in EU MDR. The goal of PMCF is to continuously gather clinical data on the performance and safety of your device throughout its entire lifecycle. That includes:

• Identifying previously unknown side-effects and monitoring identified side-effects and contraindications
• Identifying and analyzing emergent risks on the basis of factual evidence
• Ensuring the continued acceptability of the benefit-risk ratio
• Identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct

It’s important to understand that there are a wide range of activities you can undertake to meet the requirements of PMCF. A lot of MedTech companies are working under the misconception that carrying out your post-market clinical follow-up means undertaking a PMCF study. 

However, that’s not necessarily the case. The goal of your PMCF is to support the claims you made about your device during the conformity assessment. And while that could mean you need to conduct a clinical study, there are many other PMCF activities that you could carry out which would fulfill the PMCF requirements. 

In this article, I’ll walk through the various types of PMCF activities, as well as diving a little deeper into some of the most common clinical activities and how to carry them out in compliance with Good Clinical Practice (GCP).

What’s the difference between specific and general PMCF activities?

There are a number of PMCF activities you can undertake to get the data you need for your device, and these activities are categorized as either “general” or “specific”,  

General PMCF activities encompass a broad approach to gathering information and typically involve accessing existing data sources. In fact, this type of information gathering should already be happening in the course of putting a device on the market. General PMCF activities include:

• Feedback from users (e.g. from patients)

• Screening of scientific literature

• Gathering of clinical experience gained (e.g. from physicians)

• Other sources of clinical data, such as published data and research on similar devices

General activities can be useful in gathering clinical data, but they’re typically not enough to meet the necessary standards for illustrating the performance and safety of a device. The data you obtain from them is often subjective and the quality can vary widely. For example, clinical performance is difficult to prove based solely on subjective physician surveys. 

General activities will likely need to be combined with specific PMCF activities, which include methods like:

• PMCF studies (or observational or non-interventional clinical investigations)
• Post-market interventional clinical investigations
• Evaluation of data from suitable registries
• Investigator-initiated studies
• Case cohorts
• Other subject-specific clinical data collection activities

Specific methods are implemented proactively and they are typically controlled and managed by the manufacturer with the express purpose of obtaining data on a device’s performance.

FREE RESOURCE: Click here to access the on-demand webinar with TÜV SÜD on PMCF requirements under EU MDR.

Carrying out surveys and studies for your PMCF

Given that you’ll likely need to carry out multiple types of PMCF activities, I want to take the time to expand on some of the more common methods for gathering clinical data on your device. This is not an exhaustive list of the activities you can carry out, but it should give you an idea of your options and some of the pros and cons of various methods.

Subject surveys

Subject surveys can be a good option if you have direct access to study subjects. These surveys can often be designed to capture data about subjects that are not identifying, e.g., asking for an age range rather than a date of birth.

The benefit of de-identified data is that it can still provide information on patient characteristics without being categorized and regulated as protected health information (PHI). Delivery of the survey is typically very simple, and you can use methods like directing patients to a URL on the company website or placing a QR code on the packaging or device itself. 

However, the downside to these surveys is that they are inherently subjective. You may not be able to cover safety endpoints in these surveys, which means they probably won’t be applicable for all types of devices (such as Class III devices). Subject surveys are also not ideal for capturing data on patients over a long period of time, as you could with a clinical investigation, but they typically require fewer resources and can still help collect data on performance or safety.

Physician surveys / case studies

Physician surveys and case report studies are another option if you have direct access to physicians. Many manufacturers have sales reps or product managers in the field who have relationships with clinicians and can help build awareness of a survey or case report study, essentially acting as your “boots on the ground.”

Physician surveys and case report studies can provide you valuable, case-specific data. And with careful survey and case report design, you can still gather that data without including identifiable patient information. These surveys or case report studies may not be optimal for Class III devices, however, which require long-term follow-ups. Still, physician surveys and case report studies don’t require the same level of effort from either manufacturers or clinicians which would be involved in clinical investigation.

PMCF studies, registries, investigator-initiated studies

These three clinical activities are not identical, but they are similar in that they’re often multi-institutional and use more traditional enrollment methods with inclusion/exclusion criteria and follow ups. They also require closer control of data collection and defined study endpoints. 

The benefit to PMCF studies, investigator-initiated studies, and registries is that you can be more confident that the data you capture will be of high enough quality to report to a notified body and support your claims. For that reason, these types of studies are very common for Class III devices. Just keep in mind that these studies will require more time for follow-up with subjects, so you’ll need to collect other data in the meantime to support your reporting. 

These studies will also need to be carried out according to GCP requirements. The gold standard for GCP is ISO 14155:2020, the international standard for the clinical investigation of medical devices, and you’ll need to comply with its data collection requirements in order to use the clinical data you obtain.

Electronic data capture requirements under ISO 14155:2020

ISO 14155:2020 provides general specifications and requirements for the design, conduct, reporting, and data management of clinical investigations of medical devices. And since capturing high-quality clinical data is the end goal of any clinical investigation, the standard includes requirements for electronic data capture (EDC) tools that must be met for the data collection to be consistent with GCP.

According  ISO 14155:2020, any electronic data capture system must:

• Be validated “in order to evaluate the authenticity, accuracy, reliability, and consistent intended performance of the data system.”
• Ensure attributability, completeness, reliability, consistency, and logic of the data entered.
• Ensure that data changes are documented and an audit trail is maintained.
• Maintain a security system to prevent unauthorized use of data, both internally and externally. 

The best way to ensure you’re collecting and managing data in accordance with these requirements is to use an EDC system that comes pre-validated to them.

FREE RESOURCE: Click here to access the on-demand webinar with TÜV SÜD on PMCF requirements under EU MDR.

Greenlight Guru Clinical your single, compliant platform for all your PMCF data collection

When it comes to obtaining clinical data for your PMCF, you shouldn’t have to worry about compliance, complex customizations, or pharma-centric features you need to work around. 

With Greenlight Guru Clinical, you get an EDC system that comes optimized for medical devices studies—meaning you have built-in compliance with ISO 14155:2020, EU MDR, and FDA requirements. There’s no coding, no stressful setup, and no pharma-centric features you’ll never use. 

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→.