IMDRF proposes update on postmarketing device studies

Regulatory NewsRegulatory News | 20 October 2020 |  By 

The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies.
The update outlines when a PMCF study is indicated, the general principles of PMCF studies for medical devices, the design and implementation of studies, and the use of the clinical information. The document does not apply to in vitro diagnostic devices.
The proposal, which is open for consultation until 11 December 2020, was issued by the group’s Medical Devices Clinical Evaluation Working Group.
“Complete characterization of all risks and potential benefits may not always be possible or practicable in the premarket phase. Therefore, there may be uncertainties (such as rare adverse events, potential benefits, long-term safety, clinical performance and/or effectiveness,) that should be addressed in the postmarket phase using one or more systematic postmarket clinical follow-up (PMCF) studies,” the working group wrote. “PMCF studies are not intended to replace the premarket data necessary for market authorization. PMCF studies are one of several options available in a postmarket surveillance program and contribute to the risk management process.”
When to launch a PMCF study
The working group outlined various scenarios in which a PMCF study might be appropriate, such as when there are unanswered questions surrounding the long-term safety and clinical performance of a device that could not be addressed in a premarket study. A PMCF study may also be needed for novel technologies or devices with a new intended use, as well as devices used in high-risk anatomical locations or in patients with a higher severity of disease.
A postmarket study may also be needed if there are questions about how to generalize results of a premarket clinical investigation, if a device was approved based on clinical data from comparable devices, or if the device was approved as part of an expedited process during a public health emergency.
A PMCF study may also be appropriate if new safety or performance data arises through reporting of unexpected or unexplained serious adverse events. “PMCF studies may be conducted to evaluate the potential association of the safety signal and the device,” the working group wrote.
PMCF studies can also be used to provide additional information when adverse events are anticipated but rare, or to test mitigation strategies for a known risk, according to the proposed update document.
“PMCF studies may not be necessary in cases where the medium/long-term safety, clinical performance and/or effectiveness are already known from previous use of the device or where other appropriate postmarket surveillance activities would provide sufficient data to address the uncertainties,” the working group wrote.
Elements of a PMCF study
The elements of a PMCF study should include a clearly stated objective, scientifically sound study design, and an appropriate rationale and statistical analysis methods.
The objective of the study should address one of the safety or performance uncertainties and include a formal hypothesis. The working group noted that formal statistical hypothesis testing may not be necessary in some circumstances where descriptive studies are acceptable.
Study design for the PMCF is not one-size-fits-all. Appropriate study designs could include extended follow-up of patients who were enrolled in the premarket studies, a new postmarket clinical investigation, a review of data from a device registry or a review of relevant retrospective data from patients previously exposed to the device.
When conducting a PMCF, the proposed update specifies that data collection should use validated measurement methods and instruments, data should be controlled for heterogeneity, and there should be quality control over investigator selection and training. Additionally, a final study report should be developed to show if the conclusions relate back to the original objectives and hypotheses.
Ultimately, the findings from PMCF studies could inform a range of actions, including changes to the labeling or instructions for use, changes to the device design, public health notifications, or product removal. Additionally, the clinical data generated by the study becomes part of the device’s premarket clinical evidence when the sponsor applies for marketing authorization in other jurisdictions; the data can also serve to support market authorization of a next-generation product or similar technology.


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Tags: devices, EU, medical, US

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