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PMS. PMSR. PMCF. PSUR. CER. If this seemingly endless list of regulatory acronyms makes you dizzy, you’re not alone. They all refer to different postmarket surveillance (PMS) activities or processes required to maintain compliance with the EU Medical Device Regulation (MDR 2017/745). As you probably know, the MDR raised clinical data and postmarket surveillance obligations to new heights. Manufacturers must sustain a slew of postmarket activities throughout the life cycle of their device, including increased postmarket clinical follow-up (PMCF) demands and quality of data used for supporting clinical safety and performance.
PMCF is a continuous process in which a manufacturer proactively collects and evaluates clinical data about how their device is used within its intended purpose (per Annex XIV, Part B of the MDR). The data you’ll collect from PMCF supports other ongoing PMS efforts, such as clinical evaluation and risk management. PMCF is also considered part of your quality management system.
Premarket clinical data carries inherent limitations for assessing the full risk profile of a device, as its scope is limited and relatively short term. In contrast, postmarket clinical follow-up seeks to measure safety and performance as well as identify emerging risks over time and with a wider lens. According to the MDR, PMCF should seek to:
For many moderate/high risk and innovative devices, PMCF is an PMS activity, and not just because it monitors the safety and performance of your device. PMCF data and its conclusions support a number of obligatory PMS documents, which we’ll discuss in a moment. It may also identify the need for corrective and preventive actions, revisions to your labeling and instructions for use (IFU), or even changes to manufacturing processes or the device design.
This is a source of widespread confusion because the MDR is not prescriptive about how far you must go to satisfy your PMCF obligations. Because of that, most Notified Bodies have erred on the side of caution.
We have seen examples of Notified Bodies requiring PMCF ALL the time for ALL classes of devices, even for Class IIa devices which have been on the market 10+ years! In general, PMCF is only required when further clinical data from real-world experiences are needed to support the safety and performance of a device. For example, implants and new technology should conduct PMCF for a predetermined period of time to continue supporting the safety and performance of the device when in actual use. In this case, proactively obtaining real-world data from PMCF is very beneficial if not needed.
The MDR states that the PMS system should be “proportionate to the risk class and appropriate for the type of device.” However, some well-established technologies and lower-risk devices may not require PMCF, although you must justify your case for not doing so. Higher-risk devices will likely be obliged to perform PMCF as their plans should be updated annually (at a minimum), not to mention that their high-risk profiles will necessitate rigorous postmarket surveillance. In reality, most devices should submit a PMCF plan, but specific PMCF methodologies or studies may not be required for all devices.
Article 61 (11) of the MDR states: “The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer’s PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.”
If, as a device manufacturer, you need to perform PMCF under the EU MDR, then a PMCF plan would be generated as part of the post market surveillance process. The PMCF plan describes in detail how you intend to execute your PMCF strategy. Annex XIV, Part B outlines the basics requirement for PMCF but the Medical Device Coordination Group (MDCG) released a template document that removes some of the guesswork around what information to include and how to structure your PMCF plan. Here’s what your PMCF plan should cover:
You will summarize the outcome of your PMCF activities, the impact to your technical documentation, etc. in your PMCF report, which is part of your clinical evaluation report (CER). The MDCG created a template for the PMCF report as well, although the structure of a PMCF report closely follows that of the PMCF plan. Your CER should be updated periodically with the status of PMCF activities, as your Notified Body will look for this.
PMCF includes a range of activities from “general activities” to “specific activities” and you can choose the activities you undertake. General PMCF methods often produce subjective data that may not provide enough scientific evidence to demonstrate safety and performance. Specific activities employ scientific methods that are more likely to produce safety and performance data that meets industry standards, but may be more costly and challenging to execute. Here are some examples of possible PMCF activities, although this is not a complete list:
General activities:
Specific activities:
How do you choose the right methods? There is plenty to consider when choosing PMCF activities, but the most important piece is understanding the data you need and selecting the appropriate activities to produce it. Perform a gap analysis of your clinical data to determine the data you need most and let this guide your method selection process. Understand the type of clinical data required to demonstrate the safety and performance of your specific device, as it is not universal across the device types. You will have to articulate your rationale for each activity in your PMCF plan, so this is a worthwhile exercise.
Do you really need to conduct a PMCF study? It depends on the existence of known questions / data gaps about your device’s safety or whether new questions arise from other PMCF activities. Such questions might include events concerning clinical performance or use in a previously unstudied patient population. MEDDEV 2.12/2 rev. 2 can be used as a reference (it’s not required) and provides a list of circumstances in which you may need to perform a PMCF study. If enough long-term data already exists or you can adequately address the risks through other PMCF activities, a study may not be needed. In any case, you must justify and document your decision.
In addition to your PMCF report, there are other required documents in which your PMCF results should be addressed, depending on your device classification: PMS report, periodic safety update report (PSUR), and clinical evaluation report (CER). Our recommendations on CER update frequency are shown below (these are not MDR requirements).
|
MDR Device Classification |
PMS Report |
PSUR |
CER |
|
Class Is (sterile) |
As needed* |
Use PMSR instead |
2-5 years |
|
Class Im (measuring) |
As needed* |
Use PMSR instead |
2-5 years |
|
Class Ir (reusable surgical) |
As needed* |
Use PMSR instead |
2-5 years |
|
Class I (all other) |
As needed* |
Use PMSR instead |
2-5 years |
|
Class IIa |
Use PSUR instead |
At least every two years |
2-5 years |
|
Class IIb (non-implantable) |
Use PSUR instead |
At least annually |
2-3 years |
|
Class IIb (implantable) |
Use PSUR instead |
At least annually |
Annually |
|
Class III |
Use PSUR instead |
At least annually |
Annually |
*Recommended: at least every three years.
The PMS report is relevant to all Class I devices. It’s a summary of results from all your PMS activities – which include PMCF – as well as any corrective and preventive actions. PMSRs should be updated as needed and made available to competent authorities on request.
The PSUR is required for higher-risk devices and is a more robust version of the PMSR. PSURs summarize the results and conclusions of your PMS data, including main findings from PMCF, as well as your rationale and description of any preventive and corrective actions you have taken. Other conclusions are also expected, such as estimated sales volume, an updated risk-benefit-risk determination, and user population characteristics. PSURs are required for Class IIa, IIb, and III devices. (Class IIb and III device manufacturers must submit PSURs at least annually.)
You’ll also want to include a summary of PMCF results in updates to your CER, as well as whether additional PMCF or a justification for discontinuing PMCF activities will be needed. You can assess what and how much PMCF data to include in your CER based on how it illuminates the safety and performance of your device and the ongoing acceptance of the benefit-risk ratio. Read our blog on updating your CER with PMS data for a deeper dive on this topic.
PMCF is a major undertaking. With so many postmarket obligations, manufacturers must strike a balance of extracting the best-quality data possible from their PMCF activities without exhausting their resources. Take a deep dive into this essential piece of EU MDR compliance with our PMS training class. Need help complying with the MDR? Our consulting team is .
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