Post-market surveillance (PMS) under the EU MDR (2017/745) is a systematic and proactive process through which medical device manufacturers collect, analyze, and continuously evaluate data on device safety and performance after a device has been placed on the market.
The purpose of PMS is to ensure that devices continue to perform as intended in real-world clinical use, while enabling the early identification of safety concerns, performance issues, and emerging risks. This supports ongoing benefit–risk evaluation and helps maintain compliance with regulatory requirements throughout the device lifecycle.
Central to this process is the PMS plan, which defines the methods and procedures for data collection, analysis, and ongoing monitoring. Under the EU MDR, manufacturers are required to establish, implement, document, maintain, and update a PMS system for each device, in a manner proportionate to its risk class and appropriate for its intended purpose. The PMS system forms an integral part of the manufacturer’s quality management system.
A well-designed PMS system not only supports regulatory compliance but also enables continuous improvement, informed decision-making, and the safe and effective use of medical devices in clinical practice.
Adverse Event and Incident Definitions
Under the EU MDR, adverse events and incidents are defined as distinct concepts within the context of clinical investigation and post-market surveillance.
An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or any adverse clinical sign, including abnormal laboratory findings, in subjects, users, or other persons, even if it is not related to the investigational device.
An incident is defined as any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use errors due to ergonomic features, inadequacies in the information supplied by the manufacturer, or undesirable side effects.
Although these terms are sometimes used interchangeably in practice, they represent different regulatory concepts and should be distinguished within PMS and vigilance activities.
Under the EU MDR, manufacturers are required to monitor for and identify incidents associated with their devices and respond appropriately based on the severity of the event (e.g., complaint, serious injury, or death). Where a Field Safety Corrective Action (FSCA) is initiated within the EU, manufacturers must notify their Notified Body in accordance with vigilance requirements.
Trend Reporting
Trend reporting refers to the systematic analysis of incident data to identify increases in frequency or severity that may impact the device’s safety or benefit–risk profile.
Under Article 88 of the EUÂ MDR, manufacturers are responsible for identifying and evaluating statistically significant increases in incidents or expected undesirable side effects. Where such trends are identified, appropriate corrective or preventive actions must be implemented.
Trend reporting is based on data collected through post-market surveillance activities, including adverse event monitoring and vigilance reporting. A structured and continuous approach to data analysis is essential to ensure that emerging risks are identified and addressed in a timely manner.
Key Classification Documents:
MDCG 2021-24: Guidance on
classification of medical devices MDCG 2022-5: Guidance on borderline
products MDCG 2019-11: Guidance on
qualification and classification of software
Core Components of a Post-Market Surveillance System
A well-designed PMS system is structured around several core components that ensure continuous monitoring of device safety and performance throughout the product lifecycle.
These components include:
• Updating the benefit–risk determination
Ongoing assessment of clinical data, adverse events, and new information is required to determine whether the device’s benefit–risk profile remains acceptable over time.
• Clinical performance evaluation
Review of clinical data, including scientific literature and real-world evidence, supports the continued demonstration of device safety and performance in the intended population.
Monitoring and summarizing safety information
Systematic collection and analysis of adverse events, incidents, and safety signals enables early identification of potential risks.
Documentation of PMS activities and processes
All PMS activities must be clearly documented, including methodologies, data sources, analyses, and resulting conclusions, to ensure transparency and regulatory compliance.
Use Technology to Ensure Consistency
The use of digital tools can support the consistent and efficient execution of post-market surveillance activities. These tools may assist in the systematic collection, organisation, and analysis of data from multiple sources, including scientific literature and adverse event databases.
Structured use of technology can also improve traceability, reproducibility, and documentation of PMS processes, supporting compliance with EUÂ MDRÂ requirements and facilitating ongoing monitoring throughout the device lifecycle.
Incidence Reporting and Vigilance
Annex III of the MDR contains the technical documentation that is outlined in the preceding articles addressing Post Market Surveillance. Manufacturers must establish, document, implement, maintain, and update a post-market surveillance system for each device. This system must be proportionate to the risk class and appropriate for the type of device.
Manufacturers are also required to take appropriate measures based on surveillance data to address identified issues and ensure device safety and compliance.
Reporting Requirements and Timelines
Under Article 87 of the EU MDR, manufacturers are required to report serious incidents and field safety corrective actions (FSCAs) within defined timelines. These reporting requirements are based on the severity of the event and are critical to ensuring timely risk mitigation and regulatory oversight. The reporting timelines are as follows:
| Event Type | Reporting Timeline |
|---|---|
| Serious public health threat | Within 2 days |
| Death or serious deterioration in health | Within 10 days |
| Serious incident | Within 15 days |
A serious public health threat refers to an event that may result in imminent risk of death, serious deterioration of health, or significant public health impact requiring rapid intervention.
Manufacturers are required to report within these timelines from the point at which they become aware of the incident. Timely identification and escalation of such events are essential components of an effective PMS system.
Field Corrective Actions for Medical Devices
Under the EU MDR, manufacturers are required to report any Field Safety Corrective Actions (FSCAs) undertaken to address safety concerns associated with a device. For more information, you can refer to EU MDR Combination Products.
This includes FSCAs related to equivalent devices in third countries. Where such actions occur, manufacturers must assess their relevance and report them to the appropriate European authorities as part of their vigilance obligations.
Monitoring for and Identifying Applicable Events
Monitoring processes may vary depending on the distribution and complexity of the device portfolio. For devices marketed in a limited number of regions, surveillance activities may be supported through subscription to national adverse event alert systems or vigilance databases.
For devices with broader market presence or multiple equivalent products across regions, monitoring requirements become more complex, requiring structured approaches to identify and assess reportable events across multiple jurisdictions in accordance with Article 87 of the EU MDR.
For lower-risk devices (e.g., Class I), the EU MDR imposes less stringent post-market surveillance requirements. Manufacturers of these devices are required to maintain a PMS Plan and generate a PMS Report, rather than a Periodic Safety Update Report (PSUR).
Monitoring activities may include routine review of adverse event databases, vigilance reports, and other relevant data sources. The use of centralized tools or platforms may support efficient aggregation and assessment of global incident data.
The PMS Report for lower-risk devices should summarize data analysis, conclusions, and any corrective actions taken in relation to device safety and performance throughout the device lifecycle.
Monitoring processes should be clearly defined, consistently applied, and adequately documented to ensure transparency, traceability, and regulatory compliance.
Role of Notified Body in Post-Market Surveillance
The notified body plays a pivotal role in the post market surveillance process for medical devices under the EU MDR. As an independent organization designated by EU member states, the notified body is responsible for assessing and verifying that a manufacturer’s PMS system meets all MDR requirements. This includes reviewing the manufacturer’s PMS plan, evaluating post market surveillance reports, and ensuring that the processes in place are effective and compliant.
During audits and technical documentation reviews, the notified body examines how manufacturers collect, analyze, and act on post market data. They assess whether the PMS system is capable of identifying and addressing safety or performance issues in a timely manner. If gaps or deficiencies are found, the notified body provides feedback and guidance, helping manufacturers refine their PMS processes and maintain regulatory compliance.
Ongoing interaction with the notified body is essential for manufacturers, as it ensures that their PMS activities remain aligned with the latest regulatory expectations. By working closely with the notified body, manufacturers can strengthen their market surveillance efforts, respond proactively to emerging risks, and demonstrate their commitment to patient safety and product quality.
Periodic Safety Update Report
The Periodic Safety Update Report (PSUR) is a cornerstone of the post market surveillance system, particularly for higher-risk devices such as Class III medical devices and certain Class IIb devices. The PSUR provides a structured, comprehensive overview of the device’s safety and clinical performance over a defined period, consolidating all relevant data collected through the PMS system.
Within the PSUR, manufacturers must summarise the results of their ongoing market surveillance, including any new or emerging safety concerns, trend analysis, benefit-risk determination updates, and the effectiveness of preventive and corrective actions taken. This report is submitted at regular intervals—typically annually for Class III and implantable devices, and at least every two years for other specified devices—to the competent authorities or notified body for review.
By maintaining up-to-date PSURs, manufacturers demonstrate their commitment to continuous monitoring and improvement of their medical devices. The PSUR not only supports regulatory compliance but also provides valuable insights for risk management, clinical evaluation, and the overall safety profile of devices on the EU market. Regular submission and review of the PSUR ensure that both manufacturers and regulators remain vigilant in protecting patient safety and maintaining high standards of device performance.
Conclusion
Post-market surveillance is a fundamental component of the EU MDR framework, ensuring that medical devices continue to meet safety and performance requirements throughout their lifecycle.
A well-structured PMS system enables the continuous collection and evaluation of real-world data, supporting timely identification of risks, informed benefit–risk assessment, and effective regulatory compliance.
Beyond fulfilling regulatory obligations, PMS plays a critical role in maintaining device quality, guiding ongoing clinical evaluation, and supporting improvements in patient outcomes.
Ultimately, a robust PMS system reinforces a proactive, evidence-based approach to medical device safety and contributes to the safe and effective use of devices in clinical practice.
