One of the new aspects introduced in the European Medical Device Regulation 2017/745 (MDR) is post-market clinical follow-up (PMCF).
While PMCF is well-known in the pharmaceutical world, it is a relatively new concept in the medical device industry.
According to the MDR and the Medical Device Coordination Group (MDCG) guidance MDCG 2020-7, issued in April 2020, post-market clinical follow-up is a continuous process that updates the clinical evaluation and is addressed in the post-market surveillance (PMS) plan of medical devices.
In the post-market surveillance system, post-market clinical follow-up is proactive, while post-market surveillance is reactive.
In other words, during PMCF activities, you must proactively look for new post-market clinical data to update your clinical evaluation and identify potential safety issues with your medical device.
So, how do you start your post-market clinical follow-up activities? With a plan, of course!
Post-market clinical follow-up plan
The European Commission loves plans.
Post-market clinical follow-up is no different.
Annex XIV, part B of the MDR, addresses post-market clinical follow-up and outlines a set of requirements for developing PMCF plans for medical devices.
PMCF Plan Contents
Essentially, the PMCF plan is meant to:
- Confirm the safety and performance of the medical device throughout its lifetime, including the clinical benefit, if applicable.
- Identify previously unknown side effects and contraindications.
- Identify and analyze any emergent risks of medical devices based on factual evidence.
- Ensure the continued acceptability of the benefit-risk profile.
- Identify the medical device’s potential systematic misuse or off-label use to verify that the intended purpose is correct.
It is a part of the medical device post-market surveillance plan, as PMCF falls under post-market surveillance activities.
The PMCF plan outlines a strategy for collecting medical device clinical evidence.
Questions to Ask Yourself
Medical device manufacturers should ask themselves these questions before starting their PMCF plan to understand what their best PMCF strategy is:
- Can you claim equivalence with another one of your products?
- Do you have adequate justifications in place for your choices of general and specific PMCF data collection?
- Are your clinical data collection tools validated?
- Do you rely on key opinion leaders?
- Did your last clinical evaluation report identify any gaps in your clinical data?
- How do you plan to communicate with the notified body to avoid issues pertaining to PMCF activities?
The findings of PMCF are analyzed and documented in a PMCF evaluation report, which is part of the clinical evaluation report and the technical documentation for your medical device.
The PMCF report includes the same sections as the PMCF plan and documents the plan results.
So, how do I gather PMCF data?
Post-market clinical follow-up can include a variety of methods for gathering clinical evidence. Fortunately, you don’t need to use all of them.
Instead, you can choose the activities that make sense for you and your medical device.
Remember to justify the choice of activities in your PMCF plan!
Two types of PMCF activities are mentioned in the MDR: General and specific.
General Post-Market Clinical Follow-up Activities include:
- Clinical experience from clinicians
- Feedback from users and patients
- Information from scientific literature and published research
- Other sources of clinical data, such as similar/equivalent device data
General PMCF activities are not enough to adequately demonstrate your device’s clinical performance and safety, although they may provide plenty of information for some devices.
Some data collected through general PMCF activities is also subjective, such as user feedback, which makes the data unreliable to a degree.
Specific PMCF Activities Include:
- PMCF study
- Post-market interventional clinical investigations
- Evaluation of third-party registry data
- Investigator-initiated studies
- Case series and cohort studies
- Other clinical data collection activities that are subject-specific
While specific PMCF activities provide direct access to raw data, they may be out of reach for many medical device manufacturers.
It is worth noting that the MDR requires medical device manufacturers to use general and specific methods for collecting clinical data.
How Should Medical Device Manufacturers Select PMCF Activities?
There needs to be guidance on selecting appropriate post-market clinical follow-up activities, just as there is not much guidance available on providing scientific justifications for the chosen methods.
Each PMCF activity has pros and cons, and its usefulness depends on various factors.
Classification and Post-Market Surveillance Requirements
If your device is high-risk, you must provide post-market surveillance reports more frequently, which gives you less time to gather enough clinical data for your first PMCF report.
The time you have available impacts which PMCF activities you can choose.
Availability in Markets and Sales Volume
Low sales can make collecting enough clinical data from observational activities challenging.
Available Clinical Evaluation Data
The clinical evaluation report essentially serves as a gap analysis for PMCF data – how many gaps you need to bridge will impact your choice of PMCF activities. Reviewing your last clinical evaluation report with PMCF in mind can significantly help you understand which PMCF activities you should be doing.
How you measure your medical device’s performance, as well as what data is required and from where can force you to exclude PMCF activities.
Access to Customers, End-users, and Patients
Direct access to customers, end-users, and patients can open the door for PMCF surveys and other data collection activities, especially if you can coordinate collaborative efforts.
Likewise, if your end-users are hidden behind distributors, or you need access to patient data (or need to have consent to process the data), you cannot perform PMCF surveys.
The use and Application of the Device in Practice
If your medical device always requires control from clinical experts or is interventional, you may be able to collect data from clinicians and other healthcare professionals.
Even if there are registries or data sources in place for medical devices in your field, do you have applicable consent to access and process data from them?
As you can see, choosing PMCF activities requires careful consideration, as one medical device manufacturer’s PMCF activities might not work for another.
Yes, “one man’s treasure, another man’s trash” even applies to post-market clinical follow-up for medical devices. Who would’ve thought?
Notified bodies and PMCF
The most common feedback we see on PMCF from the notified bodies is the promise of PMCF activities that still need to be fulfilled.
Manufacturers mention future studies or surveys and fail to comply with or describe PMCF activities in their PMCF plan that still need to be fully realized.
Our recommendation is to not over-commit your PMCF.
A simple PMCF plan with reasonable justifications and adequate activities is better than a complicated PMCF plan, making promises for the future the manufacturer cannot keep.
You can even work with your notified body on your PMCF strategy to avoid problems.
Most notified bodies are available for negotiation around PMCF activities and proposed study plans.