Five Postmarket Surveillance-System Musts for EU Medical-Device Manufacturers

Ensuring the safety and efficacy of your medical device

Published: Wednesday, September 8, 2021 - 12:02

Designing, developing, and getting your medical device approved and onto the market is a huge accomplishment—but it isn’t the end of your responsibilities.

For the European Union (EU) market, the European Commission (EC) requires manufacturers to perform ongoing postmarket surveillance (PMS) activities once a device is placed on the market. This surveillance monitors for any potential safety or efficacy issues with the device, but it also allows manufacturers to be proactive when it comes to protecting patients.

By gathering customer feedback and other PMS data, manufacturers have an opportunity to proactively make improvements to their product or processes and prevent issues from arising in the first place.

The details of each PMS system may differ slightly from company to company, but if you plan on selling your medical device in the EU, your system must include these five components.

1. Postmarket surveillance plan

A postmarket surveillance plan is a systematic process that is designed for monitoring a specific device. Note that each individual device requires its own PMS plan. Though the plans for different devices may have a lot of similarities, you cannot simply reuse a PMS plan from one device to another.

Your PMS plan must define which data should be surveilled, how they should be collected, and how you will investigate or determine reportable trends.

The type of data collected will vary depending on the product, but a postmarket surveillance plan should always include:
• Investigations of both serious and nonserious incidents
• Reports of undesirable side effects
• Analysis of trends
• Feedback from users, distributors, or importers—including complaints
• Publicly available information about similar devices, as well as relevant information from literature, databases, or other sources

In addition, the PMS plan must address the processes used to collect these data as well as the methods used to assess the collected data. This means you will need to include the methods, protocols, or tools used for activities such as:
• Investigating complaints and other market feedback
• Identifying and analyzing reportable trends
• Identifying and initiating corrective actions
• Tracing and identifying devices that require corrective action

Your PMS plan enables better monitoring for any adverse events as well as gathering data on the long-term safety and effectiveness of the device. This is vital information that will help you gather meaningful feedback from end users, discover data trends, and make informed decisions on any updates or iterations to your product.

2. Postmarket surveillance procedures and protocols

Postmarket surveillance is only as good as the standard operating procedure (SOP) you put in place to organize and manage the data that are collected.

Your postmarket surveillance system should have an SOP that includes:
• Activity triggers. These are usually either time-based (“We do X every quarter.”) or prompted by a specific activity (a customer call, shipping the 5,000th unit, publishing a new procedure or amendment to a procedure).
• List of information sources. This might include customer feedback, service reports, employee observations, clinical follow-up studies, assessment results, and any other source of good information.
• Your PMS activities. These might include collecting, analyzing, and evaluating data before taking action on them.
• The roles and responsibilities for PMS activities. You must indicate exactly who is responsible for what within your PMS system. Use specifics when describing the activities assigned to each role.
• Documentation of PMS plan and activities. Not only must your PMS plan be documented, you also must provide evidence of the various activities that show you’re following the plan you laid out.

Huge amounts of actionable data are generated when a medical device goes to market. Without a strong SOP in place, you risk losing out on the insights that data hold for patients and providers.

3. Evidence of postmarket surveillance activities

Creating your PMS plan and establishing a well-structured SOP is an excellent start to building a strong postmarket surveillance system for your medical device. But unless you have documented evidence that you’ve been conducting the surveillance activities according to your PMS plan, all that work is for naught. From a regulator’s point of view, if it wasn’t documented, it didn’t happen.

At minimum, your postmarket surveillance system should include formal documentation of:
• How you collect the information from your data sources
• Your methodology for assessing data
• The rationale used for risk analysis
• Your methods for receiving and investigating complaints
• Your methods for determining trends
• Procedures for communicating with authorities where needed
• Device-tracing methods
• Any actions you have taken as a result of PMS

Postmarket surveillance generates a lot of documents and demands a system that has the capabilities to store and manage those data. Greenlight Guru’s quality management software does more than just streamline and automate PMS processes. The medical device success platform (MDSP) offers a secure solution for manufacturers to maintain the integrity of documents stored within a dedicated PMS system, simplifying compliance requirements from whichever market you sell your devices.

4. Postmarket surveillance report and periodic safety update report

If you’re manufacturing a Class I device in Europe, you’re required under medical device reporting (MDR) to create a postmarket surveillance report (PMSR). The purpose of a PMSR is to provide a summary of the results and conclusions of your PMS data, as well as a rationale and description of any corrective actions you took as a result of PMS activities.

For Class IIa, IIb, and III devices, the MDR requires a periodic safety update report (PSUR), which is an extension of the PMSR. The PSUR should contain a summary of your PMS results and conclusions as well as a summary of postmarket information, vigilance reporting, and the current status of the device on the market.

Finally, your PSUR must include the rationale for any corrective or preventive actions you took, such as:
• Conclusions of your risk-benefit determination
• Main findings of your postmarket clinical follow-up
• Sales volume of the device
• Estimates of the size of other characteristics of the audience using the device (plus usage frequency, if known).

Keep in mind, although the PMSR and PSUR may seem exhaustive, there’s still one more form of postmarket surveillance that your device may require.

5. Postmarket clinical follow-up and feedback system

Postmarket clinical follow-up is a proactive form of surveillance that systematically gathers clinical data on how the device is used and the outcomes of that use. It is concerned with ensuring the real-world use of a device is accurately characterized.

Postmarket clinical follow-up isn’t always necessary, but its absence must be justified in your PMS plan. All high-risk devices require postmarket clinical follow-up, and some low- or moderate-risk devices may have residual risks that could benefit from a postmarket clinical follow-up.

MEDDEV 2.12-2 Rev. 2 suggests postmarket clinical follow-up may be needed under the following circumstances:
• Novel medical technology
• High product-related risk
• High-risk anatomical locations
• High-risk target populations (e.g., children, elderly)
• Severity of disease or treatment challenges
• Unanswered questions of long-term safety and performance
• Identification of previously unstudied subpopulations that may exhibit a different benefit-to-risk ratio (e.g., hip implants in different ethnic populations)
• Verification of safety and performance of the device when exposed to a larger or a more varied population of clinical users

All postmarket clinical follow-up studies should include:
• Clearly stated objectives
• Scientifically sound design with an appropriate rationale
• Logical study plan and implementation
• Appropriate statistical analysis of data, interpretation, and conclusion

Postmarket clinical follow-up is simply an extra layer of protection for devices that require heightened postmarket surveillance. It may take more time, but your patients and your stakeholders will be glad to know it’s happening.

Streamline and automate your postmarket surveillance

Postmarket surveillance is a critical part of ensuring the safety and efficacy of your medical device, but it requires the ability to collect and manage a tremendous amount of data and documents.

With a solution like Greenlight Guru’s Intelligent Document Management, you get a secure solution for storing documents that offers seamless visibility and traceability for all your postmarket data.

First published Aug. 22, 2021, on the Greenlight Guru blog.

About The Author

Sara Adams

Sara Adams is a Medical Device Guru at Greenlight Guru and a Biomedical Engineer who began her career in the medical device industry in the post-manufacturing world. As an experienced Quality Engineer, she has been responsible for leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits.