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ISO 14971 RISK ANALYSIS

How to do medical device risk analysis?

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Post Market Surveillance Plan (PMS)

A Post Market Surveillance Plan (PMS plan)  is a systematic plan of the processes and the activities to continuously monitor the safety and the performance of the medical devices released in the market. It contains a clear strategy to be followed to collect the data which is directly proportional to the risk associated with the intended use of the medical device.

Post Market Surveillance Plan, PMS

PMS Plan and Its Importance

The PMS plan sets out the requirements for conducting the PMS activities. It is required for all devices except custom-made devices. It should be part of the Technical documentation.

 

The PMS plan should address the collection and utilization of available information, in particular:

 

  • Information regarding serious incidents, including information from PSURs, and field safety corrective actions;
  • Records mentioning non-serious incidents and data on any undesirable side-effects;
  • Information from trend reporting;
  • Relevant specialist or technical literature, databases and/or registers;
  • Particulars including feedbacks and complaints, provided by users, distributors and importers; and
  • Publicly available details about similar medical devices.

How to effectively conduct PMS Planning

  • a proactive and systematic process to collect information;
  • effective and appropriate methods to assess the collected data;
  • suitable measures and threshold values that shall be used in the continuous reevaluation of the benefit-risk analysis and of the risk management;
  • effective and appropriate methods and tools to examine complaints and analyze market-related experience collected in the field;
  • methods and protocols to direct the events subject to the trend report;
  • methods and protocols to interact effectively with competent authorities, notified bodies, economic operators and users;
  • reference to procedures to fulfill the manufacturers’ obligations for PMS system, PMS plan, and Periodic Safety Update Report;
  • systematic procedures to identify and begin appropriate measures including corrective actions;
  • effective tools to detect and identify devices for which corrective actions might be necessary;
  • a PMCF Plan per Annex III of MDR or a justification as to why a PMCF is not applicable