Types of Post-Marketing
Post-marketing surveillance studies are an important part of the regulatory process used to monitor medical device manufacturers. The primary goal of post-market surveillance of medical devices in Europe and elsewhere around the world is to provide valuable feedback to manufacturers on how their devices perform in the field and whether they should take action to address concerns about safety and efficacy. . This way, manufacturers can identify potential adverse conditions that didn’t show up during clinical trials.
Post-marketing surveillance studies can also collect and evaluate the experiences of patients who are using the devices in real-world settings.
More About Post-Marketing Surveillance Studies
Post-marketing surveillance studies, also known as post-approval studies, are conducted after a medical device has been approved for sale by regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Commission (EC).
These studies collect information on device safety, effectiveness, and long-term effects in real-world conditions. They underscore the importance of post-marketing surveillance by providing manufacturers with valuable feedback, which they can use to improve the safety and effectiveness of their products.
Here are several types of post-marketing surveillance studies that are conducted by medical device companies:
This method involves collecting and analyzing data from sources such as patient medical records, health insurance claims, and hospital databases. Passive surveillance provides a broad view of the product’s safety and efficacy but is limited because it only provides hard data on those who use the device.
Within the European Union, passive surveillance is used to collect data from multiple countries. It involves performing literature reviews and collecting data for evidence-based research that verifies the safety and effectiveness of medical device products.
This study method involves actively collecting data from a simulated or real-world environment. It can include regulatory complaints, patient feedback, interviews, and surveys to gain a more accurate view of the device’s actual performance. One example of active surveillance is the EU-MDR Post-Market Clinical Follow-up report or PMCF, which requires end-user survey data to collect direct feedback from individuals who interact with the product.
With this approach, it’s important to craft well-defined research questions so that the results bring out data relevant to a clinical study’s requirements as outlined in the Medical Device Regulation (MDR) that became effective in May 2021. This way, the data collected through active surveillance will be valid and offer meaningful insights into the safety and effectiveness of the device.
This type of study is more expensive and time-consuming than passive surveillance, but it provides more in-depth information on a device’s performance.
Epidemiological studies use data from large population groups to measure the risk of a device or technology. It is useful for identifying any potential adverse events associated with a device that might arise but weren’t observed during pre-market clinical trials.
Literature reviews are an important part of epidemiological studies, as they provide a comprehensive overview of published work on a topic and identify gaps in current knowledge. Through systematic searches, reviews allow researchers to identify relevant materials, analyze them critically, and determine the strengths and weaknesses of existing research.
By providing an up-to-date synthesis of published literature on medical devices, reviews enable medical device companies to make informed decisions on the safety and effectiveness of their products.
Post-Marketing Surveillance Studies and the MDD
The Medical Device Directive (MDD) was replaced by the MDR, which contains a more rigorous set of regulations. However, devices approved under the MDD can be brought to market until May 25th, 2025. Additional extensions have recently been debated and are in the process of being made official. The regulatory landscape of MDR is dynamic and changing frequently. One requirement that has remained constant is the need of manufacturers to conduct post-marketing surveillance studies, specifically to demonstrate that their products meet ongoing safety and performance criteria.
Post-market surveillance for the MDD can be a complex process involving several activities. Manufacturers must identify potential risks, develop strategies to mitigate those risks, and collect data both pre-market and post-market. Manufacturers must also develop effective monitoring and reporting systems to ensure that any issues are identified quickly and that appropriate corrective actions are taken.
Staying in Compliance
In the European Union, manufacturers must submit safety and performance data to the European Medicines Agency (EMA) every two years, or more frequently if there are changes to the device’s characteristics. This data must include information on any adverse events or other safety issues identified and any regulatory actions taken.
In Europe, literature reviews are a critical part of staying compliant. Manufacturers must review relevant publicly available data and conduct post-marketing surveillance studies to ensure the effectiveness of their products.
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Passive surveillance, active surveillance, and epidemiological studies are all important components of the post-marketing surveillance of medical devices in Europe. They provide manufacturers and regulators with an up-to-date synthesis of published literature, allow them to identify potential risks, and ensure the safety and effectiveness of their products.
Post-marketing surveillance studies are an essential component of the Medical Device Regulation. By following the requirements in the new regulation, manufacturers can ensure that their products are safe and effective for use after market introduction.