Post-Market Clinical Follow-Up plan (or a PMCF plan) must describe generic and specific activities (or methods) that gather data on clinical performance and safety. Until now, there’s no guidance available for manufacturers on how to select the proper PMCF activities. This blog will supply an overview of both generic and specific PMCF activities, and guidance on when and how to include them in your PMCF plan.
Before the EU MDR, the number of proactive PMCF activities, such as PMCF studies, have been limited to higher risk devices. This is largely because existing EU medical device regulations and guidelines had loopholes which many medical device manufacturers took advantage off.
The MEDDEV guidance documents are a good example of this, were some of the reasons for not to conduct PMCF studies, where largely misinterpreted by the industry, and used as an excuse to not conduct PMCF activities.
Because PMCF requirements have not been as stringent as they are now under the EU MDR, many MedTech companies have been getting by with small or none-existing clinical operations teams. And those companies who have more established clinical operations, are more used to conducting traditional clinical investigations, with traditional clinical data capture needs.
The lack of PMCF experience, together with the lack of practical guidance from the EU commission, has led to great confusion amongst industry peers on what activities to include in a PMCF plan for different types of medical devices.
The EU MDR clearly states that the goal of PMCF is to continuously gather clinical experience data on your device. Specifically, manufacturers shall gather data on both clinical performance and safety which shall be used to update the Post-Market Surveillance (PMS) and Clinical Evaluation Report (CER).
The PMCF plan is the recipe for how you intend to achieve this. In the PMCF plan, you need to document both general and specific PMCF methods to collect this information. And it’s not enough to just document which activities you will conduct, but also justify, with scientific reasoning, why and to which degree they are relevant for your PMCF plan.
But how does the EU MDR and the MDCG guideline define general and specific PMCF activities?
General PMCF activities are information-gathering operations that often produce a subjective dataset, which cannot be used alone to scientifically document safety and clinical performance, to a level which is acceptable for continued marked approval.
These can be activities such as
The last example, i.e. “other sources of clinical data” can in theory be anything, and its definition in the MDCG guidelines is absent. But in most cases, this is referring to other sources of data from similar marketed devices – such as published data and research on similar (equivalent) devices.
General methods alone, are not likely to provide sufficient data that can live up to standards needed to illustrate performance or safety. This is because the source of data is often subjective (i.e. not scientifically valid) and the quality of data can highly vary from one source to another. For example, it can be difficult to document clinical performance based on subjective surveys from physicians.
Which is why, for most devices, you often need to combine these activities with data from specific PMCF activities.
Specific PMCF activities are more “higher-level” operations that can produce a dataset that can be used to scientifically illustrate safety and clinical performance, often based on case-specific data.
These can be activities such as
All these examples have it in common to be based on patient cases where the device is being applied in practice. This produces a dataset where scientific methods can be applied to document clinical performance and safety, to a standard that is accepted by the industry and clinical practice.
The biggest pros to using specific activities is the fact that you usually gain direct access to the raw data that’s captured, which can be difficult with more general activities. Such as with screening of scientific literature. This is important to note, because the EU MDR specifies that manufacturers must be able to show clear access to the data used for clinical evaluation or PMCF when referring to clinical or safety data from equivalent devices. (It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.)
But even though the regulation and the MDCG have provided some examples for general and specific activities. What are the actual PMCF activities that medical device manufacturers are including in current PMCF plans?
At SMART-TRIAL, we have had a chance to review and provide feedback on several PMCF plans. Looking back, we've come to realize that there’s a clear harmony between the various PMCF plans and the activities selected for data gathering.
Some of the most common activities seen to date are:
Each activity has its own set of pros and cons, and it's vital to evaluate each activity together with other factors involved, before deciding on which activities to include in your PMCF plan. These factors include e.g.
Device classification and reporting requirements
Depending on the device class there might be shorter or longer time available to gather enough data for first PMCF report. This can highly impact which activity you select for your PMCF plan and how long you can conduct one to produce sufficient data.
Sales numbers and markets
If your sales are not high enough, it can be difficult to collect enough data from observational activities. Low sales will potentially require you to initiate interventional studies of some sort.
Data available from earlier Clinical Evaluations
Quality data from earlier clinical evaluations is the best indicator for the level of PMCF data needed for future activities. Depending on how much you need to “bridge” in terms of safety or performance, will impact the choice of PMCF activity selected for your PMCF plan.
Device performance measure and clinical/industry standards within the domain of interest
How is your device’s clinical performance measured? What data is required and from whom? Some activities might not fit your device, because the data originating from that activity might not suffice the standard required to document performance.
Whether you have access to customers
Do you know your customers well enough, and can you contact them directly for feedback and information? Or even collaboration? Having direct access to your customers can open the doors up for data collection activities, such as surveys.
Whether you have access to end-users
Do you know your end-users well enough to be able to contact them directly? Do they know your brand well enough for you to be able to gather survey data directly from them? Do you have their contact information, or is that blocked behind a distributor? If your answer to these questions is no, it might be difficult to gather survey-based data.
Whether you have access to the patients
Do you have consent to access data, or access to contact patients directly for patient-reported outcomes or feedback? Having data processing consents in place from patients already, is crucial to ensure compliance. You need to ensure that patients have provided consent to process their data, if you get access to a public data registry.
How the device is used/applied in practice
How is your device applied in practice? Does it always require intervention/control of clinical experts? If yes, you might not have a possibility to gather data from others than patients.
Whether there’s a data consent in place (from existing data sources)
For those existing registries or data sources that contain relevant data for PMCF, do you have applicable consents in place to gain access to these databases?
PMCF operations under the EU MDR is not a simple topic that can be easily boiled down into one blog. So, to provide a well-structured overview of each activity, this article will be published in two parts. The latter part, which will be published by the end of June 2021, will cover the pros and cons of each PMCF activity mentioned in this post.
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In the meantime, you can look at the new Practical Guide to Post-Market Clinical Follow-up EU MDR Compliance by SMART-TRIAL