In May, the new EU Medical Device Regulation (MDR) will go into effect after being delayed a year due to the COVID-19 pandemic.
That means it’s vital for medical device manufacturers to create and implement a post-market surveillance plan. Even if you are not primarily operating in the EU, post-market surveillance is a key part of protecting patients and ensuring quality products.
Here’s a closer look at how the new EU MDR impacts post-market surveillance and what steps you can take to prepare.
Understanding the EU Medical Device Regulation
The new regulation is intended to enhance safety and increase oversight. Of particular concern is the fact that existing devices will not be grandfathered. This means you will need a post-market surveillance plan for your entire portfolio, covering the lifecycle of devices. MDR covers all devices and services sold in Europe. The requirements include:
- Having appropriate risk and quality management systems in place.
- Continuing to collect clinical evidence and provide documentation to assess continued safety and effectiveness.
- Reporting data collected on devices in EUDAMED, which is also used for clinical trials.
- Classifying devices by their risk level.
- Covering your financial liability and having a specific person for regulatory compliance.
Adding or improving post-market surveillance could be one of the more challenging elements of EU MDR compliance. However, it’s important because issues can arise years after a device is on the market. Metal-on-metal hip replacements are one well-known example. Many patients began experiencing memory loss and other serious reactions due to toxic particles being released into their bloodstream when metals such as cobalt rubbed against each other. Post-market surveillance also helps identify potential new uses for existing devices.
What is the Purpose of the Post-Market Surveillance Plan?
The goal of post-market surveillance plan may vary depending on the device, but it ultimately should include:
- Tracking to determine whether problems occur late in a device's lifecycle, and to determine the optimal time when a device should be replaced.
- Ensuring instructions for use and labeling are updated to reflect issues that might be revealed after the device is on the market. For example, you may discover that providers are consistently having issues with a particular part of the insertion or installation process, which requires extra documentation.
- Identifying corrective and preventive needs to ensure devices last their full life cycle.
- Identifying opportunities to improve usability, performance, and safety.
Post-market surveillance should not be seen as mere regulatory compliance, but as a way to continue to improve your products and patient/provider satisfaction. It can also help you avoid liability issues that can arise as a product ages. For example, over the past two decades, lawsuits related to metal-on-metal hip replacements have become a considerable problem for multiple manufacturers. Spotting these problems and addressing them quickly reduces liability and helps protect your company's reputation. It can also be a way to find new off-label uses for an existing device or gather data that may be useful for the development of a successor to your device or a related product you might be working on.
How Do You Develop a Post-Market Surveillance Plan?
A post-market surveillance plan should be viewed as a research project that generally uses the data you are collecting from device recipients. In some cases, a full-blown clinical trial may be needed to gain the extra data needed to establish specific facts.
For each product, you should come up with research topics appropriate to the product and the needs of the patients using it. For example, for hip replacements, your post-market surveillance plan may include establishing how long the implant can reasonably be expected to last. From the patient perspective, the lifetime of a hip replacement is vital. Revision surgery on a hip replacement is unpleasant and expensive. Failure of the implant can cause a fall and further injury. Knowing how long your implants can be expected to last can help doctors make the right decision, depending on the age of the patient and other considerations.
This means coming up with a plan to gather the appropriate data, by recording how long patients go before revision surgery and eliminating outliers. While some outliers could be due to a defective implant, others might be caused by the surgeon or hospital. You need to properly store, manage, and analyze post-market surveillance data.
For other devices, the time frame might be shorter, or there might be specific concerns, such as usability. You cannot have a one size fits all plan, and the best way to avoid it is to make sure you ask the right questions.
It’s also important to consider the consequences of a device failing. In the U.S., the FDA requires post-market surveillance if the device meets three criteria:
- Failure of the device could have serious adverse health consequences.
- The device is intended to stay in the body for more than a year, and/or
- The device will be used outside a medical facility.
This offers guidance on when you need a post-market surveillance plan and where you should focus your attention. Once you have a plan in place, it must be implemented for as long as the devices are being used. This means you must continue post-market surveillance even on discontinued devices as long as patients are using them and, to the best of your ability, ensure that data is transferred to another company in the event of a merger or business failure so monitoring can continue for the lifetime of the device.
Requirements for Plan Notification and Reporting
Once you have your post-market surveillance plan, it must be submitted appropriately. In the U.S., you must submit your plan to the FDA for approval.
In the EU, you have two possible protocols. For Class I devices, which are considered low risk, you must produce a Post Market Surveillance Report, which includes a summary of the results and analysis of the data as well as information about preventive or corrective actions. This report can be updated whenever you feel necessary, although at least every three years is recommended. You need to make it available on request.
For higher risk devices, you need to produce a Periodic Safety Update Report, which must contain:
- A summary of results and analysis of the data in the plan.
- Information about any preventive or corrective actions.
- The main findings of post-market clinical follow-up activities.
- Conclusions on the benefit-risk determination.
- Data on sales volume, user population, and frequency of use.
The PSUR must be produced at least annually, and for Class III devices it must be submitted to the EUDAMED database. This means that you have to keep up with the data and continually store, analyze, and update it. There are potentially serious consequences for not keeping up with reporting requirements. The EU is often fast to fine and discipline companies that fail to comply with regulations, especially ones designed to improve safety.
Data management is a key part of an effective and functional post-market surveillance plan, and requires almost as much thought as the research itself.
What Should You Do for Data Management?
One key factor is to ensure you have the infrastructure in place for electronic data collection. Data will be collected from providers and patients, and in some cases, it may be produced by the device itself.
Electronic medical records systems can collect this data, and you can partner with providers, with proper concerns for patient privacy. The data can and should be stored in aggregate, separated from individual medical histories. However, you may need to cross-reference it with other conditions if you are monitoring a specific issue that might indicate a potential contraindication or other problem.
For capturing and storing the data, you can use the same data management system you use for your clinical trials. In some ways, post-market surveillance is very similar to a large population clinical trial, except that you are dealing with real world evidence, which brings additional patient privacy concerns.
Developing techniques and hardware for real-time reporting of data can help, but the data still has to be analyzed and integrated with other data. Another challenge is that because devices are not grandfathered, you may realize you need to collect retrospective data, possibly going back years, and integrate it with more current data.
The best option for most manufacturers is a full-service data management solution that can help you choose the right software, build your database, and handle data management, cleaning, and analysis. IMARC Research offers a full range of data management services, as well as monitoring, auditing, consulting, project management, and more. If you need help reviewing data, solving a specific problem, or conducting a new clinical trial, our team can support you at every step.
To learn more about how we can help you comply with the EU MDR, contact us today.