Post-market surveillance or post-marketing surveillance (PMS) is a regulatory requirement for manufacturers of medical devices that need to collect and evaluate the experience obtained from the devices placed in a particular market.
For example, as a manufacturer of a closed-loop artificial pancreas system, your goal is to ensure that the medical device is safe and efficacious for your customers. However, a situation may arise wherein the device causes a major adverse event. In such a case, you need to find out what happened so that this adverse event does not repeat.
How do you achieve this?
There is a system of reporting to generate feedback on medical devices on the market. This is called post-market surveillance.
In this article, you’ll learn:
- What is Post Market Surveillance?
- Purpose of Post Market Surveillance
- Value of Post Market Surveillance
- Post Market Surveillance Requirements
- How to Conduct Post Market Surveillance in an eQMS
- Leveraging Technology for Effective Post Market Surveillance
- Frequently Asked Questions About Post-Market Surveillance
What is Post Market Surveillance?
The US FDA defines post-market surveillance as:
“The active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.”
Thus, if you are bringing a particular medical device into the market, you must ensure that your product is risk-free. It is possible that certain risks can manifest over time, with the regular use by end-users. This is where post-market surveillance comes into play.
Thus, post-market surveillance denotes the monitoring of a medical device on the market for safety. It is a part of pharmacovigilance, i.e. drug and device safety.
Purpose of Post Market Surveillance
Post-market surveillance is crucial for a medical device’s lifecycle. When your medical device is used by a larger population, as compared to clinical trial participants, a lot more data and information becomes available.
As a result, you will get real-world evidence that provides a holistic picture of the safety and efficacy of your medical device.
Post-market surveillance aims at the following:
- Monitoring safety and efficacy of a medical device in the projected patient population
- Finding of adverse events
- Compliance with regulatory requirements
- Evaluation of a new device’s performance with current standards of care
Let us look at, for example, your closed-loop artificial pancreas system that is now available on the market. Its intended use is to facilitate patients with type 1 diabetes to adjust their blood glucose levels in an automated manner. During clinical trials, your device worked perfectly. However, on the market patients detect certain flaws that reduce their safety and efficacy.
Since you have a post-market surveillance plan in place, you can identify these flaws and make the necessary corrections.
Let us now look at the steps involved.
- Develop medical device: The R&D team in your company has improved on existing closed-loop artificial pancreas systems currently available.
- Perform initial clinical evaluation: The medical device now undergoes all mandated evaluations to prove its safety and efficacy in a target population.
- Place the improved medical device on the market: The closed-loop artificial pancreas system is now made available on the market.
- Continuous surveillance of your medical device on the market: The new medical device is constantly surveilled for any safety issues.
- Detection of adverse events: You get reports that end-users are facing certain safety and efficacy issues with your medical device.
- Update clinical evaluation and risk management: These adverse events are used to update the medical device’s clinical evaluation and risk management data.
- Decide on measures/action: You will now need to decide on what measures or actions your company must take.
- Action required?: Is any action or measure required in the first place?
- Perform actions and improve the product if necessary: The medical device now needs to be fine-tuned to remove the flaws.
- Place the improved medical device on the market: The improved medical device is now ready to be sold on the market.
Value of Post Market Surveillance
There are different stakeholders for the medical device that you have placed on the market, these include:
- You (the manufacturer)
- Provider organizations
- Regulatory agencies
Let us look at the importance of post-market surveillance for each stakeholder.
You (the Manufacturer)
Post-market surveillance gives you extra information on the disease in question. In the example cited, it is type 1 diabetes. You will also be able to compare your device with similar marketed devices.
The information that you get will help you to fine-tune your strategies concerning pricing, marketing, and clinical features of your product. You can consequently develop an upgraded product.
Clinicians and Provider Organizations
Post-market surveillance will provide clinicians and provider organizations with information about real-world patient populations. Such populations are often different from clinical trial participants.
With the information obtained, clinicians can make informed treatment choices.
Information obtained from post-market surveillance of any given medical device helps regulatory agencies decide which products are the safest, most efficacious, and cost-effective.
Post Market Surveillance Requirements
The main regulatory requirements for post-market surveillance are:
- US FDA 21 CFR Part 822: This details the post-market surveillance requirements in the USA.
- MedWatch: This is the FDA’s medical product safety reporting program for healthcare professionals, patients, and consumers.
- EU MDR: The EU requirements for post-market surveillance.
How to Conduct Post-Market Surveillance in an eQMS
As a manufacturer of medical devices, you could take the following steps to conduct post-market surveillance using digital post-market surveillance solutions:
- Create a Post-Market Surveillance Plan
- Implement the Plan
- Generate a PMS Report Based on the Findings
- Perform Vigilance Related Tasks
- Use Pre-Configured Forms for CAPAs, Complaints, NCs, Etc.
Let us look at it one-by-one.
1. Create a Post-Market Surveillance Plan
You must continuously collect and monitor data generated for your medical device. This PMS plan is part of the technical documentation for the device.
The post-market surveillance plan lists out the requirements needed for your post-market surveillance. The following details are addressed in the PMS plan:
- Information about serious adverse events and corrective actions
- Facts on non-serious incidents and undesirable side effects, if any
- Technical information, databases, and registers
- Feedback and complaints, CAPAs, Non-Conformances, etc., given by end-users, distributors
- Information on similar medical devices
With an electronic quality management system (eQMS), you will be able to cover all processes related to the PMS plan, such as CAPAs, complaints, and others which will help you save time and make regulatory compliance much easier.
2. Implement the Plan
Now that you have generated the PMS plan, you need to implement it.
Efficient QMS software will help you streamline and automate processes reoccurring processes like data collection, routing, approvals, follow-ups, reminders, email notifications, and more.
Moreover, QMS software for medical devices like SimplerQMS allows you to record NCs, audit findings, complaints, deviations, and other issues, link, and process any number of CAPAs, based on the severity.
3. Generate a PMS Report Based on the Findings
A variety of documents are generated during the PMS processes.
Post-market surveillance reporting should contain a summary of all the outcomes and decisions that were derived when the PMS data has been collected and analyzed.
It will also describe the corrective and preventive actions (CAPAs) taken by your company. Another important piece of documentation is the Periodic Safety Update Report (PSUR). The latter summarizes the results and conclusions obtained when the PMS, PMCF, and vigilance data have been analyzed.
With QMS software all the documents generated throughout your PMS activities are well organized, hyperlinked, and stored in a single, highly secure, cloud-based system. Solutions, like SimplerQMS, allow you to get an overview of NC-, Complaint-, CAPA-trending thanks to automated KPI reporting capabilities.
4. Perform Vigilance Related Tasks
Vigilance is beneficial for planning post-market clinical data information when the technical documentation of the device is done.
With a vigilance system in place, you can enable the uncovering of unknown adverse events, which will help prevent any future occurrence of such incidents.
Using eQMS reporting capabilities, you can analyze data, identify patterns, and better understand the root cause behind every complaint, non-conformance, deviation, or any other issue. This allows you to trace different quality events back to their root cause as well as correct areas of concern before they come to reality.
5. Use Pre-Configured Forms for CAPAs, Complaints, NCs, Etc.
With so many documents being generated during the PMS, you must have a proper form management process for distributing, processing, completing, and managing forms in place. This will allow you to get better data, streamline complaince and become more efficient.
When you have efficient eQMS software, like SimplerQMS, you are enabled with a powerful form management module that includes – pre-configured forms for generating CAPAs, NCs, registering complaints, etc., automated workflows, automatic data collection, and more.
Leveraging Technology for Effective Post Market Surveillance
As a manufacturer of medical devices, you will likely invest in efficient eQMS, to facilitate and automate your PMS processes.
The Quality Management Software by SimplerQMS allows the seamless recording of audit findings, NCs, deviations, complaints, etc., along with automated linking and processing of CAPAs.
With the SimplerQMS QMS software solution, you can create hyperlinks to all your products, equipment, components, suppliers, customers with relation to any post-market surveillance issue. Moreover, you can upload any file, document, record, email, etc., and associate it with any CAPA, audit, or risk. The built-in dashboards and automated KPI reports allow you to overview the status of NCs, complaints, or CAPAs, helping you achieve a more proactive approach to quality management.
Frequently Asked Questions About Post-Market Surveillance
Below are the answers to some of the common questions about post-market surveillance.
Post-market surveillance (PMS) is a regulatory requirement for all manufacturers of medical devices. It is necessary to collect and evaluate the experiences obtained after the medical device has been placed in a given market.
Post-market surveillance is essential for the lifecycle of a medical device. When your medical device is used by a larger patient population versus clinical trial participants, much more data and information is generated. The real-world evidence thus generated provides a holistic picture of the safety and efficacy of the medical device.
Vigilance is one component of the post-market surveillance system. It deals with reporting serious adverse events to the relevant authorities. On the other hand, post-market surveillance is carried out systematically by the manufacturer to review the experience obtained from their devices on the market.
The post-market clinical follow-up (PMCF) is an important part of post-market surveillance (PMS) for medical devices. The PMCF is an element of PMS that constantly verifies the benefits of your medical device and to detects previously unknown risks.
Post-market surveillance is a regulatory requirement for manufacturers of all medical devices. It is critical to a medical device’s lifecycle.
With the information that is gathered from a large patient population that uses your medical device, you will get real-world experience that will provide an all-inclusive picture of the safety and efficacy of your medical device.
SimplerQMS solution is built specifically for Life Science industries and is aligned with relevant regulations and standards. If you are interested in facilitating and automating your PMS processes, we recommend you schedule a demo to see SimplerQMS in action and talk to our experts.