Post-Market Clinical Follow-up

The concept of Post-Market Clinical Follow-up (PMCF) is designed to work along with the Clinical Evaluation of the medical device and it shall be considered as a continuous process. The origins of PMCF can be traced in Article 10 and Article 61 of the EU MDR document. There is a dedicated annex (Annex XIV – Part B) for guiding the medical device industry on PMCF Plan.

PMCF can be considered as a proactive activity in collecting the clinical data of the medical device which is in actual usage and augments the Clinical Evaluation Report (CER) already put-up for that device. The aim of PMCF is to monitor safety and performance of the medical device when it is used as per its intended use and validate the existing risk management report. The PMCF process may also identify a new risk from its clinical usage which was not thought before and provide it as input to both CER & Risk management file (RMF).

The main objectives of the PMCF includes confirming the safety and performance throughout the device lifetime, identifying unanticipated risk factors, monitoring known contraindications and warnings already put-up in the IFU, watchdogging the benefit-risk balance considering the new inputs from market and usability related issues. The objectives can be achieved through multiple options like user feedback in the form of surveys, review of scientific literature and other sources of clinical data and specially designed registers or PMCF studies, review of case reports on usability issues to name a few.

The implementation of PMCF will start with drawing up a PMCF plan and collecting the factual data from the actual usage of the medical device. The data shall be analysed and summarized in to a PMCF evaluation report which would be fed to CER and Technical Documentation. The PMCF Plan and the evaluation report shall be part of the Technical Documentation and the manufacturers shall have a strong justification if they feel that the PMCF is not applicable for them. The findings from PMCF also provide inputs to the Periodic Safety Update Reports (PSUR). The PMCF evaluation report for the class III devices and implantable devices, shall be updated at least annually.