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The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipulated by the European Union Medical Device Regulation (EU MDR).
The PMCF for medical devices is meant to be a systematic and proactive method of gathering clinical data on how your device is used and the outcomes of that use. The goal of all post-market surveillance (PMS) activities is to ensure that the medical device is performing as intended and that any potential safety issues are identified as quickly as possible.
One of the most crucial parts of your post-market surveillance activities is the post-market clinical follow-up, so today I want to dive deeper into the requirements and methods for conducting yours as well as creating the PMCF plan that will follow.
Medical device manufacturers selling products in the EU will need a post-market surveillance (PMS) plan showing a systematic process for how the device will be monitored on the market. One of those PMS activities is the PMCF and its goal is to continuously gather clinical data on the performance and safety of your device throughout its entire lifecycle.
According to EU MDR, a PMCF should also aim to:
Identify previously unknown side-effects and monitor identified side-effects and contraindications
Identify and analyze emergent risks on the basis of factual evidence
Ensure the continued acceptability of the benefit-risk ratio
Identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct
The PMCF is also part of your clinical evaluation. Annex XIV of EU MDR states that the “PMCF shall be understood to be a continuous process that updates the clinical evaluation.” In other words, the PMCF is the means by which you gather new clinical data to update your clinical evaluation.
It’s important to note here that not every medical device will need a PMCF. Article 83 of EU MDR states that manufacturers must create and maintain a post-market surveillance system that is “proportionate to the risk class and appropriate for the type of device.”
If your device is high-risk, you will be required to update your PMCF evaluation report annually. Some low or moderate-risk devices may also have residual risks that would benefit from a PMCF. Keep in mind, if you believe your device does not require a PMCF, then you must justify that decision in your PMS plan.
The PMCF for medical devices is a formal activity and cannot be performed in an ad hoc manner. You’ll need to create a post-market clinical follow-up plan that outlines the process you intend to use to gather and evaluate data for your PMCF evaluation report.
The manufacturer’s contact details
A description and specification of the medical device being studied
The activities related to the PCMF (these are both the general and specific methods and procedures you’re using)
References to any relevant parts of the technical documentation
An evaluation of clinical data for equivalent or similar devices
References to any applicable common specifications, harmonized standards, or guidance documents
Estimated date of the PMCF evaluation report
The outline of the template for your PMCF evaluation report is nearly the same as that of the plan. This should make intuitive sense, as your PMCF report simply documents the results of your PMCF plan.
The report will take the same basic structure, but you’ll include the results of the activities you undertook and the impact of those results on your technical documentation. At the end of the report, you’ll document your conclusion and how they relate to your PMCF plan.
There are many ways to gather the data you need for your post-market clinical follow-up, and you don’t need to use all of them. Rather, you should choose the activities that make the most sense for your device, as you’ll need to justify your choices in the PMCF plan.
EU MDR mentions both “general” and “specific” PMCF activities. General post-market clinical follow-up activities include:
Feedback from end users (e.g., physicians or patients)
Information from scientific literature
Other sources of clinical data
General PMCF activities alone will most likely not be enough to demonstrate the performance and safety of your device. The data you gain from these sources will often be subjective—for example, feedback from end users may vary and be based on uncontrolled variables.
That’s why you may also need to include specific PMCF activities, such as randomized clinical trials or registry studies. These kinds of specific PMCF activities offer control over the raw data and a more rigorous level of evidence.
Whichever methods you choose, they must be documented in the PMCF plan, and the results of the methods documented in your PMCF evaluation report.
Greenlight Guru Clinical is the first and only data gathering and management system that’s purpose-built for medical devices and diagnostics.
With Greenlight Guru Clinical, medical device companies can create customized eCRFs and digitize data collection for clinical investigations, in-human studies, and post-market surveillance activities.
Greenlight Guru Clinical is out-of-the-box compliant with ISO 14155:2020 and includes templates for data collection planning and regulatory compliance that help medical device companies execute organized, cost-effective, and compliant studies that bring products to market faster.
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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...