How to Keep Your Medical Device on the Market With Post-Market Surveillance
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What is Post-Market Surveillance?
Post-market surveillance (PMS) in medical devices is a systematic process that monitors the safety and performance of a medical device after it has been released on the market.
After your device goes to market, this ongoing process is used to identify potential safety issues, respond to complaints, ensure the continued effectiveness of the device, and improve future product designs.
Implementation of a PMS plan is required as part of your Quality Management System (QMS).
Does the European Union Require Post-Market Surveillance? What is it Used For?
In the European Union (EU), post-market surveillance is a necessary part of the regulatory requirements outlined in the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR); the applicable regulations depend on the intended use of your device.
The MDR applies to all medical devices, such as monitoring devices, software medical devices, implants, and even bandages.
The IVDR applies to medical devices specifically intended to analyze biological material, which encompasses blood testing equipment, pregnancy tests, or instruments. Biological material can be blood, tissue, urine, breath, or other types of biological samples. For more on IVDR vs MDR see our blog post about the differences.
Chapter VII, Section 1 (Article 83-86) of the MDR mandates that you have an active, documented PMS system in place to collect and analyze data on the quality, performance, and safety of their medical devices throughout their entire lifecycle.
It is also mandated that at least one person at your company act as the regulatory representative, with a relevant degree or at least four years of experience in regulatory affairs.
Data Collection and Usage
In order to properly keep an eye on your device after it is on the market, you have to collect different types of data on its safety and performance. This is post-market surveillance in a nutshell.
Post Market Surveillance data collection must cover
- Serious and non-serious incidents, including Periodic Safety Update Reports (PSUR), undesirable side effects, and field safety corrective actions.
- Information from trend reporting.
- Relevant specialist or technical literature, databases, and registers.
- Feedback and complaints from users, distributors, and importers.
- Publicly available information about similar medical devices.
The data you gather about your medical device is used to report to authorities or for continuous improvement of your product. Serious incidents, a rising trend in a certain type of issue with your device, or performance issues can be events that trigger a corrective and preventive action (CAPA), as per Article 83. A CAPA is essentially just a plan to handle and resolve any defect or complaint that arises after your device is released to market.
After you review your post-market surveillance data, check to see if it impacts any of the following information. If it does, it can result in a CAPA:
- Changes to the device’s benefit-risk determination and ultimately impacts to risk management
- Updates to the design, instructions for use, and labeling
- Updates the clinical evaluation, summary of safety, and clinical performance documentation
- A clinical evaluation report is a document needed for every medical device class to show that it is safe and performing as it should
- Improvements performance and usability
- Updates to risk management due to event trends or unanticipated safety issues
If a corrective or preventive action is necessary, you must create a plan, execute the plan, and ensure that the issue is resolved. Some CAPAs like those from serious safety events or major design changes may require you to inform the national competent authorities of the Member States of the European Union and/or your notified body.
Components of an EU-Compliant PMS System
MDR identifies a PMS system as a proactive and systematic process to collect information, allowing correct characterization of device performance and comparison with similar market products. To create a PMS system, you will need a PMS plan that outlines how you will gather and analyze the data on your device after it is on the market.
The PMS Plan will contain the following information:
- Effective methods to assess collected data, investigate complaints, and analyze market-related experience with tools for device traceability to identify devices needing corrective actions
- Established indicators and threshold values for ongoing reassessment of benefit-risk analysis, including statistical methods for identifying significant increases in incident frequency or severity
- Effective communication with authorities, notified bodies, economic operators, and users
- Systematic procedures to fulfill manufacturer obligations and identify and initiate measures, including corrective actions
You will report on the data you collect in your PMS plan in the form of a Periodic Safety Update Report (PSUR) or Post Market Surveillance Report (PMSR). Additionally, a Summary of Safety and Clinical Performance (SSCP) is required for some device types. These reports are summarized in the table below.
Additionally, a public facing summary of the device’s description, intended purpose and population, treatment alternatives, risks and relevant information from the clinical evaluation which is often updated when new post-market surveillance data is needs to be available.
Along with your PMS plan and reports, as part of your PMS system, you will also have a Post-Market Clinical Follow-up (PMCF) plan and PMCF report. PMCF is needed annually for all devices and includes all relevant postmarket data collected.
The PMCF plan and report work in tandem with your PMS plan and clinical evaluation and act as a way to fill in any gaps in knowledge of your device’s performance and safety. Often, if your device is low-risk and its performance and safety are well understood, you can justify why a formal PMCF plan in addition to your PMS is not necessary.
If a PMCF report is necessary, it will provide information on any post-market clinical studies, post-market interventional clinical investigations, registry data evaluations, investigator-initiated studies, and other targeted clinical data collection efforts.
Why PMS Can Be an Asset Rather Than Just a Requirement
Post-market surveillance systems can be seen as a headache for many medical device companies, but instead, you should view them as a part of your marketing and improvement strategy. Conducting PMS activities provides valuable insight into market intelligence, helps identify patient-centric innovation opportunities, informs continuous improvement strategies, and helps build brand trust.
On the financial side, one must consider the long-term cost of product failures and recalls. Early detection of issues through a robust PMS system can save money in the long run, leading to quicker resolutions and minimizing the risk of recalls or legal challenges.
PMS leverages real-world data to improve products and patient safety as well as maintain a competitive edge in the market.
Conclusion
Maintaining your medical device on the market within the European Union demands rigorous adherence to post-market surveillance (PMS) requirements as stipulated by the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). To ensure compliance, manufacturers must implement a proactive PMS system, collecting and analyzing data on device performance and safety to inform necessary corrective and preventive actions (CAPA).
Your PMS requirements in the EU will differ depending on your device class, with low-risk devices requiring Post-Market Surveillance Reports (PMSRs) and medium- and high-risk devices requiring ongoing scrutiny through Periodic Safety Update Reports (PSURs) and Summaries of Safety and Clinical Performance (SSCPs).
Manufacturers should view PMS not merely as a regulatory obligation but as an opportunity to enhance product safety, performance, and market competitiveness through continuous improvement and patient-centric focus.
Actionable tips include:
- Establishing robust data collection processes
- Regularly updating risk assessments and clinical evaluations
- Fostering open communication with regulatory authorities and the medical community.
FormlyAI: Your Partner in Medical Device Certification
At FormlyAI, we understand the complexities of MDR medical device certification. Our service provides a streamlined, efficient path to CE marking and all the tools to ensure your medical device adheres to all necessary EU regulations. All for a fraction of the cost of using traditional consultants. This way you can build your compliance documentation and apply for CE marking in a matter of weeks, not years.
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Additional Resources
- The Difference Between IVDR and MDR in the EU
- Am I a Medical Device? A Strategic Guide on EU Medical Device Classification
- What is a quality management system (QMS)? A basic guide to ISO 13485
Frequently Asked Questions
Yes, a PMCF plan is necessary for all devices regardless of their EU risk class.
Yes. As part of the regulatory requirements for the European Union (MDR 2017/745) you will need to have your post-market surveillance procedures in place prior to having your medical device on the market.
Yes, however, the processes for monitoring your device for any safety and performance issues are the same. For the EU, the classification of your device will determine what types of PMS reports you need to create.
- Class I devices: Create a PMS report every 2-5 years
- Class IIa devices: Create a PSUR every 2 years
- Class IIb and III devices: Create a PSUR annually
- Class III devices and implantables: Create a SSCP annually
You will want to include the following in your PMS system:
- Serious and non-serious incidents, including Periodic Safety Update Reports (PSUR), undesirable side effects, and field safety corrective actions.
- Information from trend reporting.
- Relevant specialist or technical literature, databases, and registers.
- Feedback and complaints from users, distributors, and importers.
- Publicly available information about similar medical devices.
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