Calculate your potential savings with our ROI Calculator
ROI CalculatorPost-market surveillance (PMS) is defined by the EU 2017/745 Medical Device Regulation (MDR) as the collection of all the activities manufacturers must undertake to keep a process going by proactively gathering and evaluating information about the operation of the device. Such activities relate to all devices sold, commercially available, or in use by manufacturers for identifying whether immediate modifications are necessary on devices. It is relevant to mention that PMS must also be included in the quality management system of a producer that is responsible for the quality assurance and compliance of the operations concerning medical devices.
The PMS system that has been introduced by the manufacturer must use the same process that is the basis of many systems in management, plan, do, check, act (PDCA) cycle. This repeatable and thorough 4-step method enables companies to gain maximum control and improve processes and products simultaneously.
The first stage that should be executed by manufacturers is the creation of a PMS plan for every medical product according to Annex III of the MDR. In the framework of this system, the manufacturer should describe the process of the establishment, documentation implementation, maintenance, and revisit of the post-market surveillance system, according to the risk classification of the medical device. The system must be made to ensure that all through the device lifecycle, related data can be thoroughly collected, documented, and evaluated.
When the plan has been put in place, and it is ensured that all the necessary conditions have been satisfied, the producer is enabled to engage into implementation activities (this is called the "do” stage of the PDCA cycle). The plan must combine proactive (i.e. activities involving events forecasting) and reactive (i.e., responding to the previous event) activities for data gathering. For instance, proactive actions include customer surveys, post-market clinical follow-up, expert user groups, field safety notices, etc. At the same time, the system should provide opportunities for reactive reporting based on feedback from complaints, maintenance/service reports, monitoring and measuring analysis, or literature reviews.
ISO TR 20416:2020 is a report that provides guidance for manufacturers on how to conduct post-market surveillance for their medical devices. Item 5.4 of ISO TR 20416:2020 states that the upper management is responsible for defining, appointing, and announcing accountability and authority for the post-market surveillance procedures. The size of the post-market surveillance team may be variable based on the firm's size, area of operation, and complexity, but sufficient representation of all functional areas in the company must be assured.
It is then necessary to point out that within the framework of Article 15 of the MDR, the firm is obliged to recognize at least one individual responsible for regulatory compliance – the (PRRC). PRRC should be responsible for a variety of issues regarding product compliance, including ensuring compliance with post-market surveillance standards. It can be thereby stated that upper management is responsible for allocating resources for post-market surveillance, while PRRC is obliged to make sure that proper coordination is carried out by post-market surveillance team members.
