The Importance of
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Post-marketing surveillance (PMS) is a regulated activity that has been mandated by the U.S. Food and Drug Administration (FDA) and European Commission (EC) for many years. Guidelines currently involve collecting, monitoring, and reviewing data to ensure that medical devices remain safe after being released to the market.
Recently, there has been an increased focus on using PMS to ensure the safety of medical products. In Europe, the Medical Device Regulation (MDR) replaced the Medical Devices Directive (MDD) in May 2021 and introduced more stringent requirements for PMS in order to maintain patient safety. The conversation around PMS also often has people wondering what post-market surveillance is for medical devices.
PMS and the MDR
The MDR is designed to ensure the safety of medical devices throughout their life cycle. One of the components of the MDR is the post-marketing surveillance system. This system is designed to track and evaluate the safety of a device after patients start to use it.
The post-market surveillance MDR system, as outlined in Article 83 of the MDR, consists of three basic elements:
- A post-market surveillance plan
- Post-market surveillance procedures
- Post-market surveillance reports (PMSRs)
The post-market surveillance plan outlines how a company will monitor their devices, and the procedures dictate how the plan will be implemented to ensure that all relevant information is collected. These procedures can solicit up to nine types of feedback during the PMS process, including insights into product risk-benefit, instructions for use and labeling, clinical evaluation, safety and performance, trends, technical documentation, corrective and preventive actions, usability and applicability to other devices, among numerous others.
The PMSRs are submitted to the relevant notified bodies, which work in conjunction with the manufacturer and competent authorities. . It outlines any incidents or complaints received relating to the device and any changes or updates made to the device. This data helps the authorities assess whether a medical device is safe to remain on the market.
How Post-Market Surveillance Helps
Post-marketing surveillance is an essential component of medical device regulation because it helps to ensure that medical devices remain safe after they have been released into the market.
Here are six reasons why post-market surveillance is so critical:
1. Ensuring Ongoing Safety
By continuously monitoring and evaluating the safety of a medical device, PMS helps ensure that patient safety is not compromised. It will identify potential safety issues associated with a product so any necessary corrective action can be taken.
2. Monitoring Effectiveness and Long-Term Outcomes
PMS will help assess a device’s effectiveness over its entire life cycle and evaluate its performance in a clinical setting. This information can be used to make improvements or changes in the future.
3. Identifying Unintended Adverse Events
PMS can help identify unintended adverse events associated with a device, such as detecting issues that weren’t identified during clinical trials. In other words, a device may work perfectly in clinical trials but could cause adverse effects in certain patient populations when used in a real-world environment.
4. Improving the Efficacy of Existing Treatments and Medications
By collecting post-market surveillance data, medical device companies can better understand how their products interact with existing treatments and medications. Based on that information, they can develop more effective and safer treatments.
5. Increasing Transparency
PMS reports provide a detailed view of how medical devices perform in the real world. This allows medical device companies to understand the risks associated with their products and make informed decisions to mitigate them.
6. Improving Communication Between Stakeholders
PMS helps to facilitate better communication between medical device companies, healthcare providers, and patients. This is important for ensuring that all affected parties understand the risks associated with medical devices and can work together to ensure patient safety.
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Post-marketing surveillance helps to ensure that medical devices remain safe after they have been released into the market. The data can come from various sources, including patient reports, regulatory and customer complaints, clinicians’ observations, and media coverage.
Medical device companies may have to use different types of post-marketing surveillance studies, such as PMS plans, PMS procedures, and PMSRs, to comply with regulatory requirements and ensure the safety of their products. By implementing post-market surveillance processes, medical device companies can ensure that their products remain safe and effective while providing increased transparency to all stakeholders.