Post Market Clinical Follow-up
PMCF is an active collection of data on clinical experience with your device after market release. PMCF activities can range from an analysis of data from literature or existing device registries to performing a new post-market clinical investigation. European and American regulatory requirements require medical device manufacturers to consider PMCF as part of their Post Market Surveillance Plan. Why? Because clinical data gathered in the pre-market phase may be too limited to identify rare events or incidents and it may not be fully representative of real-world use. Post Market Clinical Follow-up is crucial to identify any emerging or previously unknown risks and to confirm the safety and performance of the device throughout its lifetime
PMCF surveys for remote data collection
Due to the COVID-19 pandemic, many clinical investigations other than those aimed at management of the disease have been postponed or suspended
. For medical device manufacturers, this is particularly unfortunate. The EU Medical Devices Regulation (MDR) 2017/745 reinforces the rules on clinical evidence
. In practice, this means that for many devices currently on the market additional clinical data will have to be generated to enable CE-marking under the MDR. Data collection takes time, and even with the MDR’s date of application postponed to 26 May 2021
, study delays could mean that manufacturers will not have sufficient clinical evidence by the time their current CE-certificate expires.
But clinical investigations are not the only method of clinical data collection. Depending on the clinical data gap that needs to be addressed, post-market clinical follow-up (PMCF) surveys can be a valuable data collection tool. In fact, user surveys (collecting of user feedback) are listed in the MDR as a valid method of post-market clinical data collection (see MDR Annex I Part B, clause 6.2a). PMCF surveys can be performed fully remotely with no need for clinical personnel to visit hospitals and no need for patient contact.