The Post Market Clinical Follow-up (PMCF) is one element of PMS activities which can confirm the clinical performance and safety of the device and ensure continued acceptability of risk. Compared to other PMS activities, PMCFs are much more formal in nature and proactive with pre-approved outcomes or acceptance criteria. The focus is typically on certain area of performance or safety which is driven from risk management, CER or even other PMS data. A PMCF is often required where there is limited clinical data for a legacy device and becomes especially relevant when there are long term data gaps or unanswered questions associated to the use, certain indications, or novel features of a new device. As the name suggests, the activities occur after the product is CE marked and therefore the PMCF supplements the existing pre-market clinical and non-clinical data. The PMCF is required to be carefully planned with factors such as statistical rationales in areas such as patient numbers, device usage, follow-up period, outcomes and criteria in order to support the key objectives.
A PMCF can take the form of a clinical study, an appropriate registry, a customer survey, feedback from key opinion leaders, or even a planned follow-up with patients using the device. Due to the variety in types of PMCF and the need to tailor each one specifically to each device, understanding the right approach is a big challenge for manufacturers.
In order to design a successful PMCF plan, it is very important to select appropriate end points that bridge any gaps in clinical evidence and ensure that the safety and effectiveness of the device are being measured effectively to demonstrate a favourable benefit-risk profile of the medical device throughout its expected lifetime. The PMCF is a requirement for those devices where the safety and performance require further evaluation to support the pre-market data.
Apart from the factors mentioned above, a number of other points need to be considered while determining the need for a PMCF for a particular device, especially for legacy devices that have been on the market for some time but have limited clinical data or can no longer leverage equivalent device data due to the enhanced MDR requirements in this area. Under the new EU MDR, a thorough and detailed examination of all the available clinical evidence needs to be performed as part of the clinical evaluation gap assessment for existing devices in order to decide if a PMCF is warranted for a given device. If there are gaps in clinical data, a PMCF may become required in order to be successful in the MDR transition and therefore this should be identified immediately to prevent the loss of CE certification due to lack of clinical data. The MDR requires that every medical device considers the need to perform a PMCF; where not required due to sufficient clinical evidence, the rationale is required to be documented within the Technical Documentation.