Effective Post Market Surveillance (PMS) for SaMD

Now your product is on the market, it’s time to use robust Post Market Surveillance (PMS) to ensure safety and effectiveness is maintained in the real world.

Post-Market Surveillance (PMS) focuses on monitoring and assessing the safety, effectiveness, cybersecurity and overall clinical benefit of a medical device following its release onto the market. PMS is a regulated activity in almost all jurisdictions including the UK, EU and USA with increasing emphasis on PMS monitoring to verify the safety and efficacy of devices in the real world. PMS activities can also identify any previously unknown potential safety issues information that may have been missed during the clinical trial/evaluation or regulatory review process.

Medical device manufacturers are responsible to meet the post market surveillance requirements that cover the establishing of processes, maintenance, auditing and controlling the system that can oversee the safety & performance throughout the product lifecycle.

As a manufacturer, you must have a documented PMS process in place:

• Reactively capture and report on all complaints, incidents and adverse events related to their devices

• Proactively collect and stores feedback about these devices

The requirement of performing the PMS process effectively can be fulfilled by: 

• Documentation of product PMS plan

• Create PMS reports (PMS Reports, Post Market Clinical Follow up Reports, Periodic Safety Update Reports as applicable) based on the PMS plan

• Keep PMS Reports handy for the regulators during audits or submit them to Regulatory Authorities if required as per regulation

• Feed corrections and improvements (if any) to the Risk Management File, Clinical Evaluation, Benefit-Risk Analysis, device design, and labelling to update device safety and performance

• Identify needs for Corrective Actions and Preventive Actions (CAPA) or Field Safety Corrective Action (FSCA) or Recall