Post Marketing Surveillance of Medical Devices is the practice of monitoring the safety of a Medical 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.
These activities are designed to generate information in the form of a Post Marketing Surveillance Report regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behaviour and clinical outcomes.
The need for post marketing surveillance arises immediately upon 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 requirement from country specific Regulatory agency 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 Post Marketing Surveillance Report. These Post Marketing Surveillance Reports shall be updated in case of device changes.
However, PMS requirements vary greatly between different Medical Device markets which necessitates manufacturers to develop targeted strategy and avoid one-size-fits-all tactics. The EU Post Market Surveillance requirements differ significantly from that of the US FDA.
- 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 requirement
- Development of user manuals/quick start guides, post-market customer feedback (surveys)
- Regulatory support for the review and compilation of the annual reports, Post Marketing Surveillance 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 monitoring of Medical Devices
- Proactive monitoring of 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 of Medical Device post-market surveillance
- Facilitates the clearance and approval of new devices, or new uses of existing device.