Medical Device Post-Market Surveillance (PMS)

Post-Market Surveillance (PMS) for medical devices is a systematic process of monitoring device performance, safety, and effectiveness after they have been placed on the market.

PMS is required by various regulatory requirements, including the FDA 21 CFR Part 822, ISO 13485, and EU MDR. Factors such as class of medical device, target patient population, and market distribution influence the applicable PMS requirements.

The PMS process includes several key components such as developing a PMS plan, data collection, data analysis, reporting, corrective actions, among others.

PMS offers significant benefits, including enhanced patient safety, regulatory compliance, and continuous product improvement. However, limitations such as high resource demands, data inconsistencies, and complex regulatory landscapes can limit PMS efficiency.

To streamline PMS, manufacturers can implement QMS software solutions that automates data collection, provides standardized workflows, and helps reduce manual effort and errors.

SimplerQMS is a QMS software that simplifies compliance to PMS by offering tools for automated complaint handling, vigilance reporting, and risk management. Book a demo to discover how SimplerQMS can enhance your PMS processes and support other QMS processes.

What Is Post-Market Surveillance?

Post-Market Surveillance (PMS), also known as post-marketing surveillance, is a systematic process aimed at collecting and analyzing data from medical devices that have been introduced to the market.

According to the US FDA, PMS involves the active, systematic, and scientifically valid collection, analysis, and interpretation of information about marketed devices. PMS ensures that medical device manufacturers monitor their products for safety and effectiveness.

The World Health Organization (WHO) Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics identifies two primary types of PMS, categorized based on the approach and purpose of data collection.

The two main categories of PMS are listed below.

• Reactive Post-Market Surveillance: Reactive PMS focuses on issues from user feedback and adverse event reports from users, distributors, or regulators. Key activities in reactive PMS include gathering user and client feedback, adverse event reports, and complaints. It further includes on incident classification, root cause analysis, and corrective actions.
• Proactive Post-Market Surveillance: Proactive PMS anticipates and identifies potential problems before they escalate into harm or widespread issues. Proactive PMS involves observing product performance during user training or support activities, and gathering literature, and publicly available information. It emphasizes trend analysis and systematic data collection through post-market clinical/performance follow-ups (PMCF/PMPF).

Under 21 CFR Part 822 Post-market Surveillance describes specific methodologies and scenarios that imply different approaches to PMS.

The methodologies of PMS according to 21 CFR Part 822 are listed below.

• Prospective Surveillance: Prospective surveillance identifies study subjects at the start and collects data over time.
• Retrospective Surveillance: Retrospective surveillance analyzes pre-existing data to identify trends and issues.
• Device-Specific Surveillance: Device-specific surveillance addresses “surveillance questions” for specific devices. The device-specific surveillance focuses on addressing unique risks, specialized applications, and specific populations, such as pediatric patients or life-supporting devices.

What Is the Importance of Post-Market Surveillance for Medical Devices?

PMS is important to ensure the safety, efficacy, and performance of medical devices after they are released to the market and used by the public.

The main reasons why PMS is important are listed below.

• Ensure Safety and Performance: Identifies unforeseen risks and device failures that enable fast mitigation of life-threatening or long-term injuries with the aid of a post-market surveillance strategy.
• Monitor Real-World Use: Collects real-world performance data to uncover risks and limitations not evident in clinical trials.
• Align with Regulatory Requirements: Aligns with EU MDR and US FDA requirements to ensure device safety, quality, and performance across its lifecycle.
• Improve Device Design and Innovation: Integrates user feedback and performance data to drive continuous improvement and next-generation device development.
• Enhance Risk Management: Facilitates benefit-risk evaluations and trend analysis to drive corrective actions like recalls or design updates.
• Promote Patient and User Confidence: Reassures stakeholders of active device safety monitoring, fostering trust in manufacturers and regulators.
• Support Regulatory Decision-Making: Supports decisions on labeling updates, usage restrictions, or recalls, ensuring devices remain market appropriate.
• Advance Medical Knowledge: Supports evidence-based decision-making for researchers, clinicians, and policymakers by the generated insights into device performance, disease management, and patient outcomes.

What Are the Medical Device Post-Market Surveillance Requirements?

Listed below are the requirements that specify requirements for the medical device post-market surveillance.

• FDA 21 CFR 822
• ISO 13485
• EU MDR
• EU IVDR

FDA 21 CFR Part 822

FDA 21 CFR Part 822 entitled “Postmarket Surveillance” outlines procedures for FDA-mandated post market surveillance of Class II and III medical devices. This regulation focuses on medical devices that pose serious health risks, including long-term implants, or are life-sustaining. Additionally, PMS applies to devices with significant pediatric applications.

The 21 CFR Part 822 subparts are listed below.

• Subpart A – General Provisions: Defines the scope, purpose, and criteria for post market surveillance, focusing on high-risk Class II and III devices.
• Subpart B – Notification: Specifies how the FDA notifies manufacturers of post market surveillance requirements via formal orders.
• Subpart C – Post market Surveillance Plan: Outlines the content, submission, and requirements for an acceptable surveillance plan.
• Subpart D – FDA Review and Action: Describes how the FDA reviews surveillance plans and enforces compliance.
• Subpart E – Responsibilities of Manufacturers: Details manufacturers’ obligations to implement and report on surveillance activities.
• Subpart F – Waivers and Exemptions: Explains how manufacturers can request relief from specific surveillance requirements.
• Subpart G – Records and Reports: Specifies record-keeping and reporting obligations to document surveillance findings and ensure accountability.

What PMS Items Does FDA 21 CFR Part 822 Require?

The PMS items that US FDA 21 CFR Part 822 outlines requirements for are surveillance plan, gather, analyze, and assess and report the data.

Listed below are the key PMS items required by FDA 21 CFR Part 822.

• Surveillance Plan: Create a post market surveillance plan detailing methods for gathering and analyzing data on device performance and adverse effects.
• Data Collection: Collect data to assess real-world device safety and effectiveness.
• Periodic Reporting: Regularly submit reports to the FDA, summarizing surveillance data and findings.
• Adverse Event Reporting: Timely reporting of serious adverse events or critical safety information to the FDA is required.
• Record Keeping: Retain records of post market surveillance activities, including data collection and analysis, for the FDA-specified period.

ISO 13485

ISO 13485:2016 is an international standard that specifies the requirements for Quality Management Systems (QMS) in the medical device industry.

ISO 13485:2016 Clause 4.1.4 requires organizations to control QMS processes to comply with both the standard and regulatory requirements, such as PMS. Relevant ISO 13485:2016 clauses including 7.2.2 review of requirements related to product and 7.2.3 communication guidelines, aid in a comprehensive PMS plan.

Additionally, ISO 13485 requires several post-market surveillance (PMS) activities to maintain product safety and effectiveness. These include a feedback system (Clause 8.2.1) to gather stakeholder input on potential risks. Clause 8.2.2 outlines complaint handling for device-related issues. Regulatory reporting under Clause 8.2.3 mandates timely notifications of adverse events to authorities. Internal audits (Clause 8.2.4) assess PMS effectiveness, and data analysis (Clause 8.4) supports risk management and continuous improvement.

CAPA processes, outlined in Clause 8.5.2 (Corrective Action) and Clause 8.5.3 (Preventive Action), play a critical role in addressing and preventing nonconformities identified through PMS activities.

What PMS Items Does ISO 13485 Require?

ISO 13485 requires several PMS items, including a feedback system, complaint handling, regulatory reporting, CAPA processes, and data analysis.

Key PMS items required by ISO 13485 include the following as listed below.

• Feedback System: Establishes a process to gather feedback from stakeholders to identify potential safety concerns.
• Complaint Handling: Implements a system to receive, review, and address device-related complaints.
• Reporting to Regulatory Authorities: Ensures adverse events and serious incidents are reported to maintain public safety.
• Internal Audit: Ensures that post market surveillance is reviewed as part of the internal auditing process.
• Corrective and Preventive Action (CAPA): Addresses non-conformities through corrective measures to prevent recurrence.
• Data Analysis: Analyzes PMS data to manage risks and drive continuous quality improvement.

EU MDR

The European Union Medical Device Regulation (EU MDR) or EU MDR 2017/745 is a set of regulations governing both the production and distribution of medical devices in the EU. EU MDR regulatory framework replaced the Medical Devices Directive (MDD) in May 2021.

PMS requirements are mandatory for medical manufacturers under Article 10, General Obligations of Manufacturers, no. 9(i) and 10 in compliance with Article 83.

Chapter 7 entitled “Post-Market Surveillance, Vigilance and Market Surveillance” is dedicated to describing the responsibilities of manufacturers, operators, and regulatory authorities in maintaining the safety and performance of medical devices after they are placed in the market.

What PMS Items Does EU MDR Require?

EU MDR post market surveillance items involve PMS plans, reports, clinical follow-up, safety updates, and vigilance systems to ensure medical device safety and performance throughout their lifecycle.

Key PMS items required by EU MDR include the following as listed below.

• PMS Plan (Article 84): A detailed strategy for post-market monitoring, included in the technical documentation.
• PMS Report (Article 85): A summary of PMS findings required for Class I devices.
• Periodic Safety Update Report (PSUR) (Article 86): A periodic analysis of safety and performance for Class IIa, IIb, and III devices, including corrective actions.
• Post-Market Clinical Follow-Up (PMCF) (Annex XIV): A plan to continuously assess clinical performance and safety during the device’s lifetime.
• Vigilance System (Article 88): A mechanism for reporting serious incidents and corrective actions to relevant authorities.

EU IVDR

The EU IVDR refers to the European Union In Vitro Diagnostic Regulation, commonly known as Regulation (EU) 2017/746 is the regulatory framework for in vitro diagnostic (IVD) medical devices.

EU IVDR (In Vitro Diagnostic Regulation) was introduced on May 5, 2017 and replaced the In Vitro Diagnostic Directive (IVDD).

The PMS regulatory basis is defined in Article 10, General Obligations of Manufacturers, No. 8(i) and No. 9. These sections outline the requirements for setting up, implementing, and maintaining an up-to-date PMS system. Compliance with these sections should be ensured in accordance with the PMS requirements detailed in Chapter VII, Article 78 of the EU IVDR.

What PMS Items Does EU IVDR Require?

The PMS items EU IVDR mandates include a PMS plan, PSURs, PMPF, and vigilance reporting, to ensure safety, performance, and compliance of IVD devices throughout their lifecycle.

The PMS items EU IVDR requires are listed below.

• PMS System (Annex III and Article 78): A system to collect and analyze data on device safety and performance throughout its lifecycle.
• PMS Plan (Annex III and Article 79): A detailed plan outlining surveillance methods and timelines, part of technical documentation.
• Periodic Safety Update Report (PSUR) (Article 81 No. 1, Article 86(b) and Annex III): Regular updates for higher-risk medical devices to assess safety and determine CAPAs.
• Post-Market Performance Follow-Up (PMPF) (Article 81 No.1b, Annex XIII): Ongoing evaluation of the device’s performance and risk.
• Vigilance Reporting (Article 82 and Annex III): Reporting serious incidents and field safety corrective actions to authorities to protect public health.

What Other Post-Market Surveillance Guidelines Should Medical Device Manufacturers Consider?

Other PMS guidelines for medical manufacturers include references such as the Medical Device Guidance Documents (MEDDEV) and the Medical Device Coordination Group (MDCG) guidelines in the EU. In other regions, notable references include the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) and Health Canada, among others.

Medical device manufacturers may refer to additional PMS guidelines and requirements beyond local regulations when facing challenges in conducting PMS. These guidelines are shaped by factors such as the device type, associated risk, regions of market distribution, and specific regulatory updates.

Other PMS guidelines from different organizations are listed below.

• MEDDEV Guidelines: Guidance on how to conduct PMS and clinical evaluations in EU.
• MDCG Guidelines: Guidance on compliance with EU regulations, including detailed PMS and vigilance.
• DSMB (Data Safety Monitoring Boards) Guidelines: Often oversee clinical trials, including post-market phases.
• NMPA (National Medical Products Administration): Requires PMS as part of the regulatory process for medical devices marketed in China.
• MHRA (Medicines and Healthcare products Regulatory Agency): Mandates PMS for ongoing compliance and safety of medical devices in the UK.
• IMDRF (International Medical Device Regulators Forum): Provides global harmonized PMS guidelines to enhance medical device safety.
• ANVISA (Brazilian Health Regulatory Agency):  Ensures medical devices in Brazil undergo comprehensive PMS monitoring.
• COFEPRIS (Federal Commission for Protection against Sanitary Risks): Requires PMS to maintain safety and efficacy of medical devices in Mexico.
• PMDA (The Pharmaceuticals and Medical Devices Agency): Enforces strict PMS for continued safety and performance of medical devices in Japan.
• Health Canada: PMS ensures safety monitoring and license compliance for medical devices in Canada.
• TGA (Therapeutic Goods Administration): Mandates PMS to uphold Australian safety and performance standards for medical devices.

What Are the Main Post-Market Surveillance Processes?

The main PMS processes include the following as listed below.

• Develop PMS Plan: Define surveillance design such as methodology, sample size, endpoints
• Obtain Necessary Approvals: Secure Institutional Review Board (IRB) or Ethics Committee approval (if applicable)
• PMS Implementation: Includes activities such as train personnel on data collection procedures and initiate patient enrollment or data gathering.
• Data Collection: Involves gathering information from sources like clinical trials, feedback, complaints, and real-world data to assess medical device safety and performance.
• Data Analysis: Examines collected data to identify trends, safety issues, or areas for improvement, ensuring the medical device maintains a favorable risk-benefit profile.
• Reporting: Provides regular updates to regulatory bodies to confirm ongoing compliance and communicate results internally in the organization
• Risk Mitigation and Corrective Actions: Initiate corrective and preventive actions (CAPA) (if needed) and update risk management files and quality system documentation.
• Close-Out or Update PMS Plan: Conclude the PMS once objectives are met or extend/modify if new information emerges. It uses PMS insights to enhance device design, development, and current performance in the market.

The main PMS processes are illustrated in the image below.

1. Develop PMS Plan

A PMS plan details the manufacturer’s strategy for monitoring and assessing a medical device’s performance, safety, and quality throughout its lifecycle. The plan encompasses the scope, objectives, and data sources, including user feedback and adverse event reports.

To create a PMS Plan, manufacturers begin by identifying relevant regulatory requirements (e.g., FDA 21 CFR Part 820, EU MDR, ISO 13485), and obligations. Objectives are set based on device risk and use, followed by identifying data sources, methods for data collection, and analysis, along with timelines are defined. The plan integrates risk management and vigilance processes, and assigns responsibility corrective actions and reporting.

An example of the PMS plan template with minimum parameters is provided below.

2. Obtain Necessary Approvals

Obtaining the necessary approvals for PMS is necessary for compliance with regulatory, ethical, and organizational requirements. For example, ethical approvals from Institutional Review Boards (IRBs) or Ethics Committees are required for human-subject studies, along with proper informed consent procedures. High-risk medical devices, such as Class III or implantable devices, need reviews of PMS documents by notified bodies or competent authorities.

Securing approvals begins with identifying approval requirements based on the device’s classification, PMS activities, and local relevant requirements. Relevant documentation such as PMS plans and PMCF protocols are prepared and submitted to the appropriate authorities and/or ethics committees. Submissions are revised according to feedback to ensure compliance with requirements.

Once approvals are obtained, written confirmations from all parties, including internal stakeholders, are collected. These approvals and related communications are archived in the PMS file and integrated into the QMS for compliance and traceability.

Submission of appropriate documents for approvals to the ethics board is required. If no specific form is required, use the approvals template with minimum components.

An example of an approval request for PMS activity is shown below.

3. PMS Implementation

PMS implementation involves executing the PMS plan to collect data on a medical device’s performance and safety in the post-market phase. This process includes key components such as team setup, training for assigning roles and responsibilities, and educating staff on PMS processes. Data is gathered from various sources, including complaints, adverse events, PMCF studies, and usage trends.

Proper complaint handling, involving recording, investigating, and resolving issues, is essential. Serious incidents, like those causing death, significant health deterioration, or requiring medical or surgical intervention, are reported to regulatory authorities. Insights from complaints contribute to product improvements, ensuring compliance, customer satisfaction, and device safety.

Adverse events, defined as any unwanted outcome linked to the use of a medical device provide critical data for PMS and vigilance reporting. Vigilance reporting is the regulatory process for notifying authorities about specific adverse events. Through the vigilance reporting process, manufacturers, authorized representatives, and economic operators must report adverse events and safety concerns to regulatory authorities.

Lastly, usage trends, encompassing sales and distribution data, hospital records, clinical registries, and observational studies, provide substantial support for comprehensive data collection.

4. Data Analysis

Data analysis involves the systematic evaluation of real-world information on a medical device’s performance, safety, and usability after it enters the market.

This analysis is carried out by eliminating inaccuracies or duplications and then using appropriate statistical tools to analyze data and interpret the results against established targets.

5. Reporting

PMS reporting systematically communicates data, insights, and outcomes on a medical device’s real-world performance and safety. It involves providing relevant information to internal teams (e.g., management, quality assurance, R&D) and regulatory authorities to ensure compliance and drive continuous improvement.

Key activities include consolidating post-market data, drafting accurate reports, validating findings, submitting to stakeholders, and integrating feedback for ongoing enhancement.

SimplerQMS offers a comprehensive, free QMS template package upon sign-up that includes a variety of QMS templates, including the PMS report template.

6. Risk Mitigation and Corrective Actions

Risk refers to how uncertainty affects expected outcomes according to ISO 9000:2015. ISO 14971 highlights the importance of integrating risk management from the design phase, manufacturing, and post-market use.

Once a device is on the market, risk mitigation includes analyzing user feedback and adverse events, then applying controls like product updates or training to enhance safety and compliance. For device issues, corrective actions must address the root causes of problems or non-conformities. Data from risk assessments conducted are one basis for corrective actions.

7. Close-Out or Update PMS Plan

A close-out or update of a PMS plan refers to the conclusion or revision of the existing plan. This process includes reviewing data, comparing outcomes with goals, and deciding whether to close or adjust the plan.

Any changes are documented in a report, and the decision is communicated to ensure proper preparation for subsequent PMS processes.

What Are the Advantages and Limitations of Post-Market Surveillance?

The advantages of PMS are listed below.

• Improved Patient Safety: Facilitates early identification of adverse events or device failures, allowing timely interventions to protect patients.
• Regulatory Compliance: Ongoing PMS activities ensure compliance with international regulations, minimizing legal risks and penalties.
• Product Improvement: Refines device design, functionality, and safety through data and feedback from PMS
• Market Confidence: Enhances credibility among healthcare professionals, and regulators through robust PMS implementation

The limitations of PMS are outlined below.

• Resource Intensive: Implementing and maintaining a comprehensive PMS system requires significant resources, requires time, personnel, and financial investment.
• Data Challenges: Collecting data can vary widely and sometimes be insufficient for conclusive analysis.
• Reporting Bias: Underreporting or selective reporting of adverse events can distort data and affect risk assessments.
• Regulatory Complexity: Varying PMS requirements across different regions pose challenges for manufacturers operating and distributing the medical devices globally.
• Response Delays: Monitoring may not always be real-time due to logistics or communication constraints

How is Post-Market Surveillance Handled in Other Life Science Industries?

Different approaches to PMS across other life science industries are described below.

• Pharmaceuticals: Continuous monitoring of approved drugs involves tracking adverse reactions and assessing ongoing safety and efficacy.
• Biotechnology: Involving genetic and cellular therapies, PMS focuses on long-term effects and genetic impact, often requiring extended follow-up with patients.
• Food and Supplements: Monitoring includes detecting contamination, verifying labeling accuracy, and assessing health claims for consumer safety.
• Agricultural Biotechnology: Evaluates the environmental impact of genetically modified organisms (GMOs) to prevent biodiversity risks and unforeseen agricultural effects.

Pharmacovigilance

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems as defined by World Health Organization (WHO). Pharmacovigilance focuses on safeguarding patient health and enhancing public well-being by continuously monitoring the safety and effectiveness of medications after they enter the market.

The process involves healthcare providers, patients, pharmaceutical companies, and regulatory agencies contributing data to detect patterns indicating safety issues with a drug.

Pharmacovigilance includes several key activities listed below.

• Adverse Drug Reaction Monitoring: Gathering and reviewing reports of adverse reactions from patients, healthcare providers, and other sources for analysis.
• Risk Management: Identifying and mitigating risks associated with drug use through strategies designed to minimize potential harm.
• Data Management: Organizing and storing drug safety data to support regulatory reporting and safety evaluations.
• Regulatory Compliance: Ensuring adherence to laws and regulations concerning drug safety through activities such as submitting regular safety updates to authorities.

What Are the Differences and Similarities Between Pharmacovigilance and Post-Market Surveillance?

The main differences between pharmacovigilance and PMS are in the focus on healthcare products, scope, data sources, and regulatory framework. Meanwhile, the main similarities of pharmacovigilance and PMS are they are both processes in monitoring the safety and effectiveness of health products after they have been released to the market.

The differences between pharmacovigilance and post-market surveillance are listed below.

• Focus: Pharmacovigilance focuses on drug safety while post-market surveillance (PMS) focuses on the safety and performance of medical devices
• Scope: Pharmacovigilance is for drugs and vaccines while PMS is for medical devices post-market
• Data Sources: Pharmacovigilance relies on adverse drug reaction (ADR) reports, while PMS gathers data from clinical studies, product reports, and customer feedback.
• Regulatory Framework: Pharmacovigilance and PMS have their own set of requirements and guidelines.

The similarities between pharmacovigilance and PMS are outlined below.

• Objective: Both pharmacovigilance and PMS aim to ensure products remain safe and effective after-market release.
• Continuous Monitoring: Both processes involve ongoing surveillance of products throughout their lifecycle.
• Risk Management: Each process requires identifying, analyzing, and addressing risks related to product use.
• Regulatory Compliance: Manufacturers must comply with safety reporting requirements and are subject to audits and inspections by regulatory bodies.

How to Streamline Post-Market Surveillance?

Streamlining PMS processes involves integrating automated document and data collection, standardizing reporting procedures, and leveraging advanced analytics. These processes help to efficiently monitor and assess product safety and performance.

Several ways to enhance the efficiency of PMS processes are listed below.

• Streamline Document Management System: Accessibility of all documents and records related to the safety, performance, and regulatory compliance of medical devices.
• Automate Data Collection: Adopting automated systems for data collection can greatly decrease manual labor and reduce the likelihood of errors. Integrating tools such as electronic health records (EHRs) and customer relationship management (CRM) systems enables smooth and efficient data gathering.
• Standardize Processes: One workflow in a system for PMS activities ensures efficiency, and consistency and reduces complexity
• Utilize Advanced Analytics: Using advanced data analytics and machine learning algorithms enables the rapid identification of trends and patterns within large datasets.
• Update Training: Offering thorough training to staff involved in PMS activities ensures they are proficient in their tasks. This includes staying updated on regulatory changes and effectively using PMS tools and software.
• Collaborate with Stakeholders: Collaborating with healthcare professionals, patients, and regulatory authorities can enhance the quality and volume of data collected. This gives a more comprehensive view of the product’s performance.
• Update PMS Plans Regularly: Continuously evaluating and revising PMS plans based on new product developments and regulatory updates ensures PMS remains effective and relevant.

The image below illustrates various ways to streamline PMS processes.

What Is the Role of Post-Marketing Surveillance Software?

PMS software plays a vital role in supporting medical device companies to efficiently monitor and manage the safety and effectiveness of their products after they have been released to the market. PMS software automates and streamlines the data collection, analysis, and reporting of product performance data, significantly enhancing the effectiveness of PMS activities.

SimplerQMS offers comprehensive Quality Management System (QMS) software including PMS tools that help in managing various aspects of PMS. Key capabilities include complaint handling, adverse event tracking, and risk management integration. The software is equipped with robust document management capabilities for enhanced document efficiency. Furthermore, the integrated dashboards and KPI reports provide an overview of the status of NCs, complaints, or CAPAs, enabling a more proactive approach for PMS.

SimplerQMS is designed to support compliance with critical regulatory requirements for medical device companies, prioritizing regulations standards such as FDA 21 CFR Part 822, FDA 21 CFR Part 820, ISO 13485:2016, EUMDR, IVDR, and others. This helps ensure that companies meet the stringent requirements set forth by regulatory bodies while maintaining efficiency and effectiveness in their QMS operations including PMS.

For medical device companies looking to enhance their PMS activities and ensure compliance with global requirements, SimplerQMS is a significant step forward. Book a demo to gain insights into how SimplerQMS can streamline your PMS processes and support other QMS processes.