inventory_2

SOP Post-Market Surveillance

Use this SOP Post-Market Surveillance template to establish, document, and maintain your medical device post-market surveillance processes, ensuring systematic collection and analysis of safety, performance, and quality data for devices placed on the EU market. You should complete this template when your devices are commercially available, to define and manage PMS plans, reports (PMSR, PSUR), and trend analysis activities required for ongoing regulatory compliance, risk management, and improvement actions. This SOP is crucial for meeting EU MDR/IVDR requirements and demonstrating proactive vigilance throughout your product’s lifecycle.
Generate ->

SOP Post-Market Surveillance

ID: eget-ornare-nisl

1. Purpose

This document describes the Post-Market Surveillance (PMS) processes.

2. Scope

This process applies to all medical devices created by the company that are on the market in the EU. The post-market surveillance system shall be suited to actively and systematically gathering, recording and analyzing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions. This SOP covers all products that have been released by the manufacturer but can include feedback that occurs during the development process.

3. Related Documents

  • SOP Vigilance
  • SOP Corrective and Preventive Actions
  • SOP Change Management

4. Post-Market Surveillance Updates

Each device will have its own PMS plan to describe the specific PMS activities required for that device. Reports as a result of the PMS plan will be included in a report that will differ based on the device classification.

5. Post-Market Surveillance Data

The technical documentation for the device will be updated accordingly based on the type of data received. Not all data received through PMS requires an update to the above listed technical documentation.

There shall be cooperation with the competent authorities as it relates to market surveillance as outlined in Chapter VII, Section 3, as applicable, as allowed by the implementation window designated for the EUDAMED system.

6. Post-Market Surveillance Plan

A PMS plan is to be created for each device that will be placed on the market. The post-market surveillance plan shall address the collection and utilization of available information, in particular:

  • information concerning serious incidents, including information from 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, including feedbacks and complaints, provided by users, distributors and importers; and
  • publicly available information about similar medical devices.

Additionally, the post-market surveillance plan shall cover at least:

  • a proactive and systematic process to collect any information. The process shall allow a correct characterization of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
  • effective and appropriate methods and processes to assess the collected data;
  • suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;
  • effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field;
  • methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
  • systematic procedures to identify and initiate appropriate measures including corrective actions;
  • effective tools to trace and identify devices for which corrective actions might be necessary; and

The PMS plan shall be updated as necessary based on changes to the device, new regulatory requirements, or other changes that require it to be updated.

7. Input for Post-Market Surveillance

Product feedback (Input) is collected actively and systematically through procedures described in the post-market surveillance plan. These can include but are not limited to:

  • field complaints,
  • scientific literature,
  • vigilance databases,
  • post-market clinical follow-up data,
  • product surveys and focus groups,
  • service and installation reports, and
  • defective and nonconforming product.

8. Output for Post-Market Surveillance

Data gathered by post-market surveillance system can be used to update the following, as relevant depending on the type and impact of the data received:

  • to update the design and manufacturing information, the instructions for use and the labelling;
  • for the identification of needs for preventive, corrective or field safety corrective action;
  • for the identification of options to improve the usability, performance and safety of the device;
  • when relevant, to contribute to the post-market surveillance of other devices; and

Design changes are managed through the SOP Change Management and affiliated processes.

9. Post-Market Surveillance Report

A Post-Market Surveillance Report (PMSR) shall be created according to the PMS plan. The PMS report shall be created by the quality team and reviewed by the Person Responsible for Regulatory Compliance (PRRC) as needed.

The report should contain information regarding the main findings from post-market surveillance activities as well as any additional relevant information from the quis-tortor-velit if needed.

10. Periodic Safety Update Report

A periodic safety update report (PSUR) shall be created for each device and where relevant for each category or group of devices summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan.

The PSUR shall include the following as relevant:

  • A comprehensive analysis of data collected during the post-market surveillance plan reporting period
  • Data on device sales, use, installs, and distribution where possible.
  • An updated evaluation of the device's safety and performance, including a benefit-risk assessment if needed, considering newly acquired post-market data.

11. Trend Analysis

Trend reporting shall be incorporated as part of the PMS system with methodology described in the PMS plan and analysis reported in the post market surveillance report or PSUR, depending on the device classification.

Any statistically significant increase in the frequency or severity 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 and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits shall be reported on in the PMSR or PSUR.

The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.

All collected post-market surveillance information must be reviewed against the device's risk management file.

Medical Device Certification Made Easy.