Post Market Surveillance

surveillance

What is Post-Market Surveillance ?

PMS is the process conducted by manufacturers and regulatory bodies to monitor the performance of medical devices after they have been released to the market. It encompasses a range of activities, including gathering and evaluating clinical data, customer feedback, and information on adverse events.

Key Components of PMS :

  • Data Collection : Methods for gathering relevant data on the device’s performance, which may include customer feedback, clinical studies, and reports of adverse events or malfunctions.
  • Data Analysis : Assessment of collected data to detect any trends or patterns that may indicate a safety concern or an opportunity for product improvement.
  • Corrective Actions : Implementation of necessary actions in response to findings, which may include product recalls, modifications, or issuing safety warnings.
  • Communication with Stakeholders : Informing healthcare professionals, patients, and regulatory bodies about important findings or actions taken in response to PMS data.
  • Documentation : Maintaining records of all PMS activities and findings to demonstrate compliance with regulatory requirements.

Challenges in Post-Market Surveillance :

  • Data Volume and Quality : Managing and analyzing large volumes of data from diverse sources.
  • Regulatory Compliance : Adhering to evolving and varied post-market regulations across different regions.
  • Rapid Response : Quickly identifying and responding to safety concerns raised by PMS data.
  • Technological Changes : Keeping up with advancements in technology that may impact the performance or safety profile of the device.
  • Global Coordination : Coordinating PMS activities across different markets and regulatory environments.

Periodic Safety Update Reports (PSUR) :

PSURs are comprehensive reports that manufacturers of medical devices are required to compile and submit at regular intervals. These reports are essential under the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

  • Purpose of PSUR : The primary objective of a PSUR is to continually reassess the risk-benefit analysis of a device. It helps to identify any new risks or changes in the known risks and evaluates the impact of these risks on patients.

  • Contents of PSUR : A typical PSUR includes:

    • An update on the device's cumulative sales volume and estimated population exposed to the device.
    • A summary of the device’s benefit-risk determination and any changes since the last report.
    • Analysis of new or emerging risks and a summary of the results of any PMCF studies.
    • A synopsis of any corrective or preventive actions taken.
  • Frequency and Submission : The frequency of PSUR submission varies based on the device classification, with higher-risk devices requiring more frequent updates. PSURs must be submitted to the relevant regulatory authorities and, under the EU MDR, are also stored in the European Database on Medical Devices (EUDAMED).

Post-Market Clinical Follow-Up (PMCF)

PMCF is a part of PMS focused on gathering clinical data following the commercialization of a medical device.

  • Purpose of PMCF:

    • Confirm the safety and performance of the device throughout its expected lifetime.
    • Identify previously unknown side-effects or emerging risks.
    • Gather data on the long-term effectiveness of the device.
    • Ensure the continued acceptability of identified risks.

  • PMCF Activities : These may include:

    • Conducting additional clinical studies or trials.
    • Systematic literature reviews.
    • Analysis of registry data or data from other sources.
    • Gathering feedback and data from users and healthcare professionals.
  • PMCF Plan and Report : Manufacturers must develop a PMCF plan outlining the methods and procedures for collecting and evaluating data. The findings are then compiled into a PMCF report, which feeds into the overall PMS system and the PSUR.

How Medfins International will help you!

  • Strategic Planning for PMS : Developing comprehensive PMS strategies that include effective PMCF activities and timely PSUR compilation.
  • Regulatory Expertise : Providing guidance on regulatory requirements and submission processes for PSUR and PMCF documentation.
  • Data Analysis and Reporting : Assisting in the analysis of post-market data and the preparation of PSUR and PMCF reports.
  • Quality Assurance and Compliance : Ensuring that all PMS activities, including PMCF and PSUR, comply with regulatory standards and quality assurance requirements.