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Post Market Surveillance

Comprehensive Post Market Surveillance Solutions for Medical Devices

  2. Services
  3. CE Certification Consultancy
  4. Preparation of Post Market Surveillance Documents

Post-market surveillance (PMS) is a system that provides continuous feedback on the performance of medical devices on the market, ensuring a high standard of product quality. It is an essential part of regulatory requirements, and the Medical Device Regulation (EU MDR) and IVDR post market surveillance place significant importance on collecting clinical and safety-related data after the approval/CE certification process and market access. The data gathered from medical device post market surveillance serves as critical input for updating technical documents such as clinical evaluation, Risk analysis, usability, etc.

Manufacturers of MD and IVD devices must implement a robust system to gather and review experience from their devices in the post-production phase. Notified Bodies (NB) are responsible for auditing and verifying the effectiveness of the PMS post marketing surveillance system. Such medical device post market surveillance systems are an essential part of a manufacturer’s quality assurance framework. In most cases, these systems already exist to fulfill internal company requirements, function as an integrated part of a manufacturer’s quality system, and comply with third-party regulations. Even in the absence of an approved quality system, manufacturers are still required to maintain an effective post-market surveillance (PMS) system.

Main-purposes-of-Post-Market-Surveillance

Main purposes of Post Market Surveillance (PMS)

  • Monitoring medical device safety and performance
  • Identification of the scope of improvement in the design and performance of the devices.
  • Meeting regulatory requirements
  • Contributing to life cycle management
  • To update relevant technical documentation like clinical evaluation, risk analysis, etc.
Main-purposes-of-Post-Market-Surveillance
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Post Market Surveillance and ISO 13485 relationship

Post-market surveillance is an integral part of the requirements laid out by ISO 13485 as well as the EU MDR post-market surveillance guidelines. Post-market surveillance not only ensures ongoing compliance but also helps in identifying new opportunities for improvement related to the medical device, in accordance with ISO 13485. Additionally, it provides valuable input into the design and development change processes, as stipulated by ISO 13485.

The MDR post-market surveillance should be a key component of the company’s Quality Management System (ISO 13485), ensuring continuous monitoring of the device's performance and safety. By analyzing the data on quality, performance, and safety throughout the device’s lifecycle, post-market surveillance enables proactive decision-making. A post-market surveillance report for medical devices is essential for tracking the effectiveness of corrective actions and addressing any identified risks, ensuring the device remains safe and effective in the market.

 

ISO 13485-QMS ISO TR 20416-PMS
  • 4.1.1 The organization shall document the role (s) undertaken by
  • 5.4.2 Quality management system planing
  • 5.6 management Review
  • 7.3 Design and development
  • 8.2 monitoring and measurement
  • 8.4 Analysis of data
  • 8.5 improvement
  • 4 purpose of post market, serveillance process
    • monitoring medical device safety and perfomance
    • meeting regulatory requirement
    • contributing life-cycle management
  • 5.5 Data collection
  • 5.6 Data Analysis

Relationship between ISO 13485 and Post-market surveillance (PMS)

Post Market Surveillance Plan (PMS)

A Post Market Surveillance (PMS) Plan is a documented strategy of the proactive process for the collection of any required information to evaluate the safety and performance of the medical device released in the market.

The PMS plan contains the requirements of Article 84 & Annex III of EU-MDR to be followed for the collection of data, which is directly proportional to the risk associated with the intended use of the medical device.

The EU MDR post market surveillance plan shall address the collection and utilization of available information, in particular:

  • Information concerning serious incidents, including information from Periodic Safety Update Report (PSURs), and field safety corrective actions;
  • Records referring to non-serious incidents and data on any undesirable side-effects;
  • Information from trend reporting;
  • Relevant specialist or technical literature, databases, and/or registers;
  • Information from feedback and complaints provided by users, distributors, and importers; and
  • Publicly available information about similar medical devices.

Additionally, for IVDR post market surveillance, manufacturers must ensure compliance with regulations applicable to in vitro diagnostic devices, ensuring all relevant data is gathered and assessed for performance and safety.

The MDR post market surveillance is designed to ensure continuous monitoring of medical devices after they have been placed on the market, helping to maintain safety standards throughout the device lifecycle.

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How to conduct Post Market Surveillance (PMS) Planning

A proactive and appropriate process to collect any information shall allow a correct characterization of the performance and safety of the devices and enable a comparison to be made between the device and similar or equivalent products available on the market. This is a critical aspect of medical device post-market surveillance (PMS), which ensures ongoing safety and effectiveness.

  • Prepare a Post Market Surveillance (PMS) plan as per the requirements of Article 84 and Annex III of EU-MDR.
  • Execute the Post Market Surveillance (PMS) plan.
  • Prepare a Post Market Surveillance (PMS) report based upon the data.
  • To assess the collected data, use effective and appropriate methods and processes.
  • Appropriate indicators and threshold values should be used in the ongoing reassessment of the benefit-risk analysis of the risk management system.
  • Use effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field.

Methods and protocols to manage the events subject to the trend report for medical devices, including the methods and protocols to be used to establish any statistically significant increase in the frequency of incidents that are not serious or expected undesirable side-effects, which could have a significant impact on the benefit-risk analysis as well as the observation period.

  • Procedures and protocols to communicate effectively with competent authorities, notified bodies, economic operators, and users.
  • Reference to procedures to fulfill the manufacturer’s obligations for Post-market surveillance (PMS).
  • Systematic procedures to identify, analyze, and initiate appropriate measures, including corrective actions against non-conformities or complaints associated with the medical device.
  • Implement effective methodology to trace or identify problems associated with devices for which corrective actions might be necessary.
  • Prepare a Post-market clinical follow-up (PMCF) plan as per Annex XIV, or provide justification if PMCF is not applicable.
PMS Infographic
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How Maven can help in Post Market Surveillance (PMS) documentation

  • Provides expert guidance in conducting medical device post-market surveillance (PMS) and its associated activities.
  • Preparation of PMS plan, Post Market Surveillance (PMS) report
  • Provides well-structured PMS plan, procedures, Post Market Surveillance (PMS) draft report
  • Identifies the Post Market Clinical Follow-up (PMCF) requirements for a device or Justification for not conducting Post Market Surveillance (PMS)
  • Implement the effective methodology to trace or identify the problem associated with devices for which corrective actions might be necessary; and
  • Analyzing and drawn-up conclusions from Post Market Surveillance (PMS) data

Frequently Asked Questions

A Post-Market Surveillance (PMS) plan for medical devices is a documented strategy that outlines how a manufacturer will proactively collect and analyze data on the performance and safety of a device once it is on the market. Required under EU MDR Article 84 and Annex III, it includes sources like user feedback, incident reports, and scientific literature. The PMS plan helps identify risks, track trends, support regulatory compliance, and ensure the device remains safe and effective throughout its lifecycle.

Post-market surveillance methods include proactive data collection through user feedback, complaint analysis, trend reporting, literature review, and data from registries and databases. Manufacturers also analyze incident reports, conduct Post-Market Clinical Follow-up (PMCF), and assess Periodic Safety Update Reports (PSURs). These methods help monitor device safety, identify risks, and ensure continued compliance throughout the device’s lifecycle.

Yes, ISO 13485 requires manufacturers to implement a post-market surveillance (PMS) system as part of their quality management system. While the standard does not define detailed PMS procedures, it emphasizes the need for monitoring, data analysis, and continual improvement of medical devices. Clause 8 of ISO 13485 outlines requirements for feedback, complaint handling, and analysis of post-production data, which align closely with EU MDR/IVDR post-market surveillance expectations.

An example of post-marketing surveillance is collecting and analyzing data from users about adverse events or complaints related to a medical device after it has been released in the market. For instance, if a surgical implant shows unexpected side effects during use, manufacturers gather this data through reports, analyze the root cause, and take corrective actions such as product updates or safety notices. This helps ensure continued device safety and regulatory compliance.

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