Post Market Surveillance Study (PMS)

Post Market Surveillance (PMS), is the ensemble of the processes and activities to monitor the performance of a medical device. These activities are designed to produce information that are related to the usage of the device in order to quickly determine the issues related to the design and/or the usage of the device and characterize the clinical results and the product behavior of the device in real world. The need of PMS comes in view after the commercialization of the device. However, it is extremely important to handle the PMS process within the initial design stage of the product and to conduct it with the available data that can be found through the equivalent or same-similar products in the market in order to produce a device proper to the expectancy of the market and the legal necessities. The PMS study should be conducted proper to the Meddev 2.12-1 Rev.8 Guide.

The PMS study can be conducted under two main topics as the reactive approach and the proactive approach:

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​Reactive PMS: Including quality information, safety or the performance of the device in the market and the complaints and adverse events that are reported by the users, necessary information is ensembled reactively through the assessment of the producers. This approach includes the studies that will be done after the event occurs in the PMS process. Subjects that are handled in this approach, are stated below.

  • Customer Complaints
  • User Feedbacks (excluding the complaints)
  • Maintenance/service reports (if any)
  • Standard controls/ tests in the company
  • Truelife adverse events and product withdrawals related to the products of the company
  • Reporting regarding these circumstances to the competent authorities (related ministry of health and approved facility)

Proactive PMS: Additional information about the quality, safety or the performance can be assembled proactively with the routine production parties’ verification tests/controls. During the PMS process, this approach includes the studies that will be done before the event happens. The purpose of this approach is to define the issues that causes the dangers and risks before clinical safety and performance problems that are related with the medical device happen. Subjects that are handled in this approach, are stated below.

 

  • The assessment of the withdrawal and the adverse event reports of the

present equivalent/ same-similar products

  • The assessment of the information obtained from the adverse events or withdrawals regarding the producer’s own products
  • Customer expectations and suggestions that are obtained from the customer feedback processes
  • Information oriented at customer expectations and suggestions that are obtained through sales channels (sales team, distributors, dealers…etc.)
  • Process measurements and nonconformity / corrective and preventive action (capa) analyses
  • Assessment of the information obtained from the quality control processes such as necessary tests, examinations and experiment that are done during and after mass production
  • Current Clinical Literature Assessments
  • Periodic Risk Assessments
  • Revision of the present design and determination of the alteration needs after supply to the market
  • Carrying out the clinical experiments after the obtainment of the CE Marking including, if any, PMCF (Post Market Clinical Follow-up)
  • Information about the clinical performance and safety that are obtained by the observation of the medical device market requirements
  • Standard, regulation, legislation, law or guideline requirements that includes the new or revised regulations