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Post-Market Surveillance Report

Use this Post-Market Surveillance Report template to systematically collect, analyze, and summarize safety and performance data for your medical device after it has been placed on the market. Completing this report is essential every two years (or as requested by a notified body) to document vigilance data, complaints, incidents, and trend analyses, ensuring ongoing regulatory compliance and proactively identifying risks or needed improvements to your device. This template helps you fulfill EU MDR Article 84 and related requirements by providing structured evidence of your device’s post-market safety and performance.
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Post-Market Surveillance Report

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1. Scope

This report describes the results of post-market surveillance (PMS) activities. This report is a result of the processes described in SOP Post-Market Surveillance and the PMS plan. This report concerns PMS data related to VitaCare Device.

This template will utilize data from other documentation but you will need to fill in any missing details. This should be completed every 2 years at most, usually a notified body will request it.

2. PMS Data Inputs

PMS data was collected from various sources. The PMS report addresses the following information, if relevant:

  • 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 was 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 is included in the following sections below.

2.1 Vigilance Data

Vigilance data from the following sources were 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 were used to identify vigilance data:

vita, care, device, monitoring, adverse event

The following data were collected and analyzed:

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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 (FSCA), 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 following table includes relevant complaints data:

Fill in this table with your sales volume and complaints data. For the complaint rate, use the formula Complaint Rate = Complaints / Sales Volume.

2.3 Corrective and Preventive Actions

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2.4 Serious and Non-serious Incidents

This section provides an overview of serious and non-serious incidents that occurred during the surveillance period. Serious incidents are required to be described in detail while non-serious incidents are summarized and any non-serious incidents that were not already identified in the risk management file are described.

Fill in the tables below with data captured from your complaints data or vigilance data on your device only. If you have no data for a particular section, you can put N/A in the table.

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 data used for the analysis includes complaint data and vigilance data collected over the surveillance period. The data is 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.

You will need to perform a Mann-Kendall analysis here to determine if there are any trends in your data. If you are not familiar with this test, you can use a statistical software package to perform the analysis.

4. Conclusion and Impact of PMS Data

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