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Post-Market Surveillance Plan

Use this Post-Market Surveillance (PMS) Plan template to systematically outline how you will collect, analyze, and report safety and performance data for your medical device after it has been placed on the market. This document is essential for meeting EU MDR and FDA requirements, guiding you on vigilance data sources, complaint handling, trend analysis, and corrective actions, and should be filled out before product launch and regularly updated during the device’s lifecycle. Completing this plan ensures you proactively identify and address risks, maintain regulatory compliance, and provide the necessary input for your PMS or PSUR reports.
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Post-Market Surveillance Plan

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1. Scope

This plan describes post-market surveillance activities. This plan is a result of the processes described in SOP Post-Market Surveillance. The results of the execution of the PMS plan are described in the PMS report or the periodic safety update report (PSUR). This plan concerns PMS data related to Consectetur adipiscing elit sed do.

2. PMS Data Inputs

PMS data is collected from various sources. The PMS plan shall address the collection and utilization of available information, in particular:

  • information concerning serious incidents, including information from PSURs (as applicable), and field safety corrective actions;
  • records referring to non-serious incidents and data on any undesirable side-effects;
  • information from trend reporting, if available;
  • relevant specialist or technical literature, databases and/or registers;
  • information, including feedbacks and complaints, provided by users, distributors and importers; and
  • publicly available information about similar medical devices.

This information is collected and analyzed as a normal process according to SOP Clinical Evaluation, SOP Post-Market Surveillance, SOP Feedback and Complaint Management, SOP Vigilance, SOP Corrective and Preventive Actions, and SOP Risk Management. If data acquired through these processes is applicable to the PMS inputs and within the surveillance period, it shall be included in the PMS report without any additional data action required.

2.1 Vigilance Data

Vigilance data from the following sources are considered:

  • FDA Manufacturer and User Facility Device Experience (MAUDE) - The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
    MAUDE - Manufacturer and User Facility Device Experience
  • FDA Recall - This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated.
    Medical Device Recalls
  • German Federal Institute for Drugs and Medical Devices (BfArM) Database - In according with the Act on Medical Devices (MPG) and the German Safety Plan for Medical Devices (MPSV), the Federal Institute for Drugs and Medical Devices (BfArM) ensures the central collection, analysis and evaluation of risks arising from the use or application of medical devices, in particular, adverse effects, interactions with other substances or products, contra-indications, falsifications, operational defects, malfunctions and technical defects and in so far coordinates the necessary measures to be taken.
    BfArM website
  • Swissmedic - Swissmedic is the Swiss authority responsible for the authorisation and supervision of therapeutic products. Swissmedic's activities are based on the Law on Therapeutic Products.
    Swissmedic

The following keywords can be used to identify vigilance data:

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2.2 Complaints Data

Data from the complaints management system is considered for this section. Any information concerning serious incidents, including information from PSURs (as applicable), field safety corrective actions, records referring to unknown non-serious incidents and data on any undesirable side-effects, and information, including feedbacks and complaints, provided by users, distributors and importers determined to be relevant shall be included in a report of PMS data (PMSR or PSUR, as needed).

The number of complaints should be compared against the sales or install volume of the device in order to generate a complaint rate.

2.3 Corrective and Preventive Actions

A summary of corrective and preventive actions for the device shall be provided in the report. Additionally, any field safety corrective actions on similar devices identified through vigilance searches or other data inputs should be considered as well.

2.4 Serious and Non-serious incidents

Serious incidents identified during the surveillance period will be considered in the PMS or PSUR report. A summary of the incidents and the actions taken will be included.

Non-serious incidents and undesirable side effects will be summarized in the PMS or PSUR report. The summary will include the number of incidents and the nature of the incidents that were not already covered by the risk assessment.

3. Trend Reporting

It is required to report any statistically significant increase in the frequency or severity of incidents that could impact the benefit-risk analysis and pose risks to the health or safety of patients, users, or other individuals. This section outlines the methodology for trend analysis, with a specific focus on the Mann-Kendall test, tailored to the characteristics of the device and its market performance. Other statistical tests may be used if they are more appropriate for the data, including the Nelson Rules, a Weibull Analysis, a regression test, or a Neumann trend test.

3.1 Trend Analysis Methodology

The Mann-Kendall test is a non-parametric statistical test designed to identify trends in time series data, making it well-suited for post-market surveillance analysis. The PMSR or PSUR report will include the results of the Mann-Kendall test, which will be used to identify trends in the data.

The data used for the analysis will include complaint data and vigilance data collected over the surveillance period. The data will be ordered by time and the Mann-Kendall test will be used to identify trends in the data. Significance will be determined using a p-value of 0.05, or other values as appropriate for the data. A positive value indicates a positive (increasing) trend, a negative value indicates a negative (decreasing) trend, and a value near zero suggests no trend.

Should the trend analysis find that the estimated probability or severity of risks were too low, reporting will be performed as needed according to SOP Vigilance and SOP Corrective and Preventive Actions and the risk management file will be updated accordingly.

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