Post-Market Surveillance (PMS) for Medical Devices

The collection of all processes and activities used to monitor the performance of medical devices is called Post-Market Inspection (PMS). The need for PMS arises immediately after the commercialization of the device. However, in order to produce products that comply with market expectations and legal requirements, it is extremely important that the preliminary PMS process is handled at the initial design stage of the product, and that it is carried out with the available data that can be accessed especially through equivalent/similar products in the market.

PMS should generally be executed in accordance with MEDDEV 2.12.1 Rev.8 and ISO 20416 Guidelines.

PMS work can be executed in 2 ways.

– Reactive
– Proactive

Reactive PMS: Complaints and adverse events related to the medical device, including information about the quality, safety or performance of the device collection as reagent is called reactive PMS. It covers the necessary studies after the event in the PMS process. This approach addresses the following issues.

– Customer Complaints
– User Feedback (Non-Complaint)
– Maintenance / Service Reports
– Quality Assurance routine tests and controls
– Medical Device-Related Adverse Event and Product Withdrawal Reporting

Proactive PMS: Routine batch verification with additional information on quality, safety and performance in Proactive PMS, which covers studies before the event occurs It can be collected proactively with tests/controls. The purpose of Proactive PMS is to detect safety and performance problems of the Medical Device before it reaches the consumer.

– Examining the manufacturer's adverse events related to their products and data obtained from product recalls
– Customer expectations and recommendations from customer feedback processes
– From sales channels (dealer, distributor) Data on customer expectations and suggestions obtained
– Process measurements and nonconformities
– Examination of product recalls and adverse event notifications regarding equivalent/equivalent products available in the market
– Required testing during and after production and analysis of the data obtained from the quality control processes of the analyzes
– Clinical literature review data
– Periodic risk assessments
– After the product is placed on the market, reviewing the current design and revealing the need for changes, if any, Post-CE marking clinical trials, including clinical follow-up