POST-MARKET Clinical follow-up

A Post-Market Clinical Follow-Up (PMCF) Plan is triggered by several factors throughout the lifecycle of a medical device. One of the main triggers is the requirement for ongoing compliance with regulatory standards, particularly under the EU MDR, which mandates that manufacturers continuously monitor the safety and performance of their devices once they are on the market. A PMCF Plan is typically initiated as part of the overall post-market surveillance (PMS) system and is required to gather real-world clinical data that may not have been fully captured during pre-market clinical studies.

Triggers for implementing or updating a PMCF Plan include the introduction of a new device to the market, changes in the device's design, intended use, or target population, and when the initial clinical evidence is insufficient to confirm long-term safety and efficacy. Additionally, new safety concerns, adverse events, or emerging risks identified through post-market surveillance or literature reviews can also prompt the need for a PMCF Plan. The plan is designed to address these uncertainties by systematically collecting and analyzing post-market clinical data, thereby ensuring that the device remains safe and effective throughout its use in the market.

General PMCF activities are routine and ongoing processes designed to collect and analyze clinical data across the entire population using the device. These activities are not targeted at specific issues but rather focus on gathering comprehensive, real-world evidence to confirm that the device continues to perform safely and effectively in its intended use. Examples of general PMCF activities include regular reviews of clinical literature, surveys of users and healthcare professionals, and the analysis of data from post-market surveillance systems. These activities help to ensure that the device maintains a favorable benefit-risk profile over time and that any broad trends in device performance or safety are identified.