Importance of Post Market Surveillance for medical Devices
Post market surveillance (PMS) activities are part of the manufacturer’s overall quality management system, whereby it provides continuous feedback about a device on the market, ensuring that a high standard of product quality is maintained, as it monitors the safety of the device post launch.
PMS is a requirement for the main markets i.e. US, Europe, Australia, etc. In Australia, the Therapeutic Goods Administration (TGA) is responsible for medical devices, this includes the monitoring of the ongoing safety, performance and quality, of devices which have been included on the Australian Register of Therapeutic Goods (ARTG). In Europe with the introduction of the MDR (EU) 2017/745, one of the major changes is an increased focus on post market surveillance.
PMS is a system to monitor and review experience gained from marketed devices. PMS should be established and implemented immediately upon the commercialisation of the device and be conducted throughout the commercial lifecycle of the marketed device.
PMS should be conducted periodically and cover the period since the last review. The periodic review can be based on the class and risk of the device. The requirements for PMS are directly proportional to the risk associated with the device and it’s intended use.
The manufacturer will identify the potential inputs, gather and analyse data from production/manufacturing, customers and patients. It can be broken down into two forms – reactive and proactive, these are combined to form the basis of the Device PMS’ plan.
Examples of reactive inputs:
- Medical device reports
- Non conformance
- Maintenance/service reports
Examples of proactive inputs:
- Literature review
- Post market clinical follow up
- Customer surveys
- Production monitoring
Effective PMS will ensure the device remains safe and effective once it has been placed on the market. If your organisation needs help developing a PMS system, contact KD&A and we can help you with your PMS requirements.
TGA Medical Device Class I Update – Changes to the Australian Register of Therapeutic Good (ARTG) inclusion process for non-measuring, non-sterile Class I medical devices
November 9, 2020
June 4, 2020