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Post Market Surveillance

Post Market Surveillance

Post-market surveillance (PMS) is a system that gives continuous feedback about the performance of devices on the market in order to maintain a high standard of product quality. It is an essential part of regulatory requirement and the Medical Device Regulation (EU MDR) and In-Vitro Diagnostic Regulation (IVDR) gives special importance to gathering clinical and safety-related data after the approval/CE certification process and market access.

Manufacturers of MD and IVD devices must have an appropriate system for gaining and reviewing experience in the post-production phase from the range of devices he manufactures. NB has to audit to verify the effectiveness of the PMS system. Such systems are an essential part of a manufacturer’s quality assurance system. In most cases, Post-market surveillance (PMS) systems already exist to meet internal company needs, as an integrated part of a manufacturer’s quality system, and/or to meet the requirements of third parties. In the absence of an approved quality system, the manufacturer is still required to have effective Post-market surveillance (PMS) system in place

Main purposes of Post Market Surveillance (PMS)

  • Monitoring medical device safety and performance
  • Meeting regulatory requirements
  • Contributing to life cycle management
  • To update the clinical evaluation

Post Market Surveillance and ISO 13485 relationship

Post-market surveillance can also recognize the new opportunities for improvement associated with the medical device in accordance with ISO 13485. Furthermore, it provides input into the design and development change processes, in accordance with ISO 13485. The Post Market Surveillance (PMS) should be an integral part of the company’s Quality Management System (ISO 13485) to analyze the data on quality, performance, and safety of the medical device throughout its lifecycle.

 

ISO 13485-QMSISO 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 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.

PMS plan contains a requirements as per the requirement 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 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 feedbacks and complaints which are provided by users, distributors and importers; and
  • Publicly available information about similar medical devices.

How to conduct Post Market Surveillance (PMS) Planning

  • A proactive and appropriate process to collect any information and shall allow a correct characterization of the performance and safety of the devices and comparison to be made between the device and similar or equivalent products available on the market;
  • Prepare a PMS plan as per the requirements of Article 84 and Annex III of EU-MDR,
  • Execute the PMS plan
  • Prepare a PMS report based upon the data
  • To assess the collected data, use effective and appropriate methods and processes;
  • Appropriate indicators and threshold values that shall 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 or of incidents that are not serious incidents or that are expected undesirable side- effects that 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 the non-conformity or compliant associated with the medical device;
  • Implement the effective methodology to trace or identify the problem associated with devices for which corrective actions might be necessary; and
  • Prepare PMCF plan as per Annex XIV, or give justification if PMCF is not applicable.
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How Maven can help in Post Market Surveillance (PMS) documentation

  • Provides guidance in conducting Post-market surveillance (PMS) and its activities
  • Preparation of PMS plan, PMS report
  • Provides well-structured PMS plan, procedures, PMS draft report
  • Identifies the Post Market Clinical Follow-up (PMCF) requirements for a device or Justification for not conducting 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 PMS data

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