Importance of PMS data
Post Market Surveillance (PMS) refers to the requirement that manufacturers monitor their medical devices post approval. PMS is a regulatory requirement in significant markets, including the European Union (EU) and the United States (US).
PMS involves reactive data gathering. Manufacturers collect and report adverse events from various resources or databases. These adverse events are either directly reported to the manufacturer or they could be reported to Regulatory bodies like FDA in the US (MAUDE database), MHRA in the UK, Health Canada in Canada etc.
Manufacturers are required to investigate each Medical Device Report and inform regulatory authorities within the specified period to provide an assessment on whether the event is device related or not. This process is reassessed to assure the medical device’s benefit/risk ratio as well as its safety and effectiveness in the post-market phase.
PMS is a critical part of a device’s lifecycle: monitoring the device in use by a larger population provides more data than clinical trial phase. This real-world evidence offers an ongoing and more complete picture of the safety and effectiveness of a device.
PMS activities involves following steps:
a) Defining Post-marketing surveillance objectives
b) Surveillance planning
c) Data collection, receipt and pre analysis
d) Analysis of surveillance data
Post PMS analysis, the results could lead to
a) Corrective and preventive action management
b) Communication with customers to improve the device performance
c) Change in the intended use
In summary, medical device manufacturers use real-world evidence from PMS to:
a) Detect adverse events as part of pharmacovigilance
b) Compare a new device’s performance against current standards of care
c) Comply with regulatory requirements
d) Continue to monitor the safety and effectiveness of the device in the intended patient population
KN CONSULTING AND SERVICES is a well-oiled marvel in the field of Medical devices regulatory consulting. We can provide you with flexible and detailed planning and consulting services suiting to your needs.