Post-Market Surveillance (PMS) for Medical Devices

The European Union Medical Device Regulation (EU MDR) 2017/745 Post-market Surveillance (PMS) requirements necessitate a well-defined Regulatory strategy tailored to a medical device's risk profile. Freyr offers expertise in developing PMS strategies, evaluating existing data for compliance, and ensuring timely compliance.

Post-Market Surveillance (PMS) for Medical Devices Overview

Post-Market Surveillance (PMS) for Medical Devices is the practice of monitoring the safety of the device after it has been released in the market. PMS guidelines are a collection of processes and activities used to monitor the safety, performance, and effectiveness of Medical Devices.

A post market surveillance plan is designed to generate information in the form of a Post Market Surveillance report regarding the use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behavior and clinical outcomes. 

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The need for a post market surveillance planarises immediately upon the commercialization of the device. Ensuring adequate medical input into the risk management process during device development will help manufacturers characterize possible product safety issues. It is important to note that the post-marketing surveillance requirements should be directly proportional to the risk associated with the device based on its intended use. A post-marketing surveillance plan must be provided as a part of the assessment for device certification based on requirements from country-specific regulatory agencies and should be based on available clinical data and an assessment of residual risks. The results of the PMS data shall be periodically submitted in the form of a Post Marketing Surveillance report. The Post Marketing Surveillance report shall be updated in case of device changes.

However, EU MDR post market surveillance (PMS) requirements vary greatly between different Medical Device markets, requiring manufacturers to develop a targeted strategy and avoid one-size-fits-all tactics. For instance, the EU MDR's Post Market Surveillance (PMS) requirements vary significantly from those of the US FDA.


Post-Market Surveillance (PMS) for Medical Devices

  • Development of PMS strategy for the device based on risk profile.
  • Identifying the requirements of the EU MDR Post Market Surveillance, IVDR Post Market Surveillance, ISO 13485-2016, 21CFR, and guidance documents to enable effective implementation of a post-market surveillance system.
  • Evaluating existing PMS data for ensuring target country-specific compliance.
  • Ensure vigilance reports are completed on time and in compliance with local requirements.
  • Development of user manuals/quick start guides, post-market customer feedback (surveys).
  • Regulatory support for the review and compilation of the annual reports, and Post Marketing Surveillance (PMS) reports.
  • Leverage PMS data to support compliance with the new regulations.
  • Plan and implement the post-market clinical follow-up activities.
  • Support for product recall, complaint handling, and Medical Device reporting, as per country-specific regulations.
  • Timely and accurate information on the benefits and risks of medical device monitoring.
  • Proactive monitoring of the market and implementation of Regulatory updates.
  • Identifies potential safety issues in real time from a variety of privacy-protected data sources.
  • Continuous collection, analysis, and delivery of PMS data.
  • Utilize post-market data effectively for business benefits.
  • Support for effectively managing complaints or field safety action responses.
  • Reduced burdens and cost-effective approaches to Medical Device post-market surveillance.
  • Facilitates the clearance and approval of new devices or new uses of an existing device.

For end-to-end regulatory partnership on PMS, reach out to Freyr