Post-market surveillance (also known as Post-Marketing Surveillance or PMS) refers to the requirement that manufacturers monitor their medical devices after being approved for sale and seeing in-market use. PMS is a regulatory requirement in significant markets, including the European Union (EU) and the United States (US).
Traditionally, PMS relies on reactive data gathering. Manufacturers collect and report adverse events from a device post-market, often using manual methods. These adverse events are either directly reported to the manufacturer or they could be reported to Regulatory bodies like FDA in the US (MAUDE database), MHRA in the UK, Health Canada in Canada etc. Since 2021, additional requirements are needed to earn a UKCA mark as well.
Manufacturers are obligated to investigate each medical device report (MDR) and inform the regulatory authorities within a given time period, to provide their assessment whether the MDR was a device related event. This approach continues to reassess medical device’s benefit/risk ratio as well as its safety and effectiveness in the post-market phase.
However, technological advances and increased regulatory requirements—particularly the more stringent ones included in the new European Medical Device Regulation (EU MDR)—are pushing a more proactive process. The enhanced regulatory requirements are also requiring for the post-market surveillance process to have a feedback loop with Design Quality, Clinical Evaluation and Technical Documentation to utilize real-time performance data of the device to anticipate and curtail events before they occur.
This blog provides an overview of PMS, including links to PMS resources, and examines vital PMS compliance requirements and deadlines in the EU and US.
What is post-market surveillance for medical devices?
PMS refers to monitoring a medical device post-market for safety and is part of pharmacovigilance, or drug and device safety. PMS is a critical part of a device’s lifecycle: monitoring the device in use by a larger population provides much more data and information than that collected in the clinical trial phase. This real-world evidence offers an ongoing and more complete picture of the safety and effectiveness of a device.
Collecting quality, performance, and safety data throughout a device’s lifetime helps manufacturers build a complete risk/benefit profile for their device and rapidly course-correct should any issues arise. As part of PMS, manufacturers also collect data on related devices from competitors.
These data can be collected as part of vigilance analysis – internal vigilance by manufacturer established internal databases that collect post-market customer complaints, failure analysis or adverse event reports, or external vigilance by country specific regulatory authorities medical device reports databases. The internal vigilance data is typically compared to the sales figure of the devices to continue to assess its risk/benefit ratio. EU-MDR is one of the first regulations to document expectations for reassessment of calculated risk ratios during the development of a device with real world vigilance and sales data in the post-market phase.
Systematic and periodic literature search as well as continuous monitoring through publication alerts for manufacturer’s and competitor’s devices can alert for off label use in populations and indications for which the device is not intended.
In summary, medical device manufacturers use real-world evidence from PMS to:
- Detect adverse events as part of pharmacovigilance
- Compare a new device’s performance against current standards of care.
- Comply with regulatory requirements
- Continue to monitor the safety and effectiveness of the device in the intended patient population.
How do you conduct post-market surveillance?
At a high level, manufacturers must take these steps to conduct PMS:
- Develop a PMS plan, which includes an assessment of whether Post-Market Clinical Follow-up (PMCF) is required
- Implement the plan
- Generate PMS reports based on the findings
A PMS plan details a manufacturer’s strategy for continuously monitoring and collecting data and safety information on its device. The PMS plan is part of the device’s technical documentation and outlines the criteria for the risk/benefit assessment of the device and processes for:
- Collecting and analyzing data
- Following up on collected complaints
- Communicating information to regulators and users
- Taking corrective actions on devices
- Producing a PMCF plan, or a rationale for why PMCF is not required
Reporting requirements vary by region, as seen below. Most reports typically include data analysis and a description of the corrective and preventative actions taken.
- In the US, the FDA requires that manufacturers submit a Periodic Adverse Drug Experience Report (PADER/PAER).
- In the EU, manufacturers of low-risk Class I devices must create a post-market surveillance report (PMSR). Manufacturers of Class IIa, Class IIb, and Class III devices must submit a periodic safety update report (PSUR).
These reports are part of a device’s technical documentation, and manufacturers must update them regularly according to the relevant regulatory bodies’ timelines.
Post-market surveillance in the US and EU
Manufacturers must comply with PMS regulations for the region where they sell their devices.
US PMS Requirements
You can access the US requirements via these links to the pertinent sections of the Code of Federal Regulations (CFR) and the US Food and Drug Administration (FDA):
- 21 CFR Part 822 details the requirements for PMS in the US.
- The FDA uses MedWatch for health care professionals and consumers to submit adverse event reports.
- FDA also utilizes the MAUDE database to house medical device reports submitted to the FDA by mandatory reporters – manufacturers, importers and device user facilities and voluntary reporters such as health care professionals, patients and consumers.
- The FDA also conducts PMS activities; see a full list of PMS requirements for medical devices here.
In short, a device’s class determines requirements, with higher-risk devices more likely to require PMS. Class I medical devices typically do not need PMS, as they are lower risk.
European Union PMS Requirements
In the US, PMS is required only for higher-risk devices. However, in the EU, EU MDR not only mandates PMS for all devices but introduces new and expanded requirements that increase compliance efforts. Annex III of the MDR 2017/745 details the EU requirements for PMS.
Also, note that any manufacturer with a device planned for sale in the EU must prove that it has performed Post-Market Clinical Follow-Up (PMCF) plan for their medical devices or justify its omission. PMCF is one component of PMS activities, and the two main criteria for mandatory PMCF are the device’s risk and novelty. Specifically, devices with high-risk designations and those that are the first of their kind require PMCF.
Download our white paper “What does the MDR tell us about post-market surveillance” for more information. And for more details on PMCF and how it can create value for manufacturers, check out our blog on PMCF benefits.
The EU market also has a deadline looming, as the new EU MDR takes effect on May 26, 2021. Manufacturers should ensure that their PMS processes are fully compliant by this date.
Conclusion
With the deadline to comply with the EU MDR only a short time away, manufacturers must act quickly to understand PMS requirements and develop a plan. No matter where you are in the implementation process, working with a trusted partner with experience helping organizations with regulatory preparedness and submissions is critical. Castor is a trusted partner with deep expertise in clinical trials for the medical device market, one that can help you optimize PMS elements within EU MDR and US regulatory guidance.
Schedule a demo today and take the first step on your journey to identifying the most relevant PMS solutions and collecting the quality PMS data you need.