Post Marketing Clinical Follow-Up (PMCF)

As per EU MDR, Post Marketing Clinical Follow-up (PMCF) is a continuous process where device manufacturers need to proactively collect and evaluate clinical data of the device when it is used as per the intended purpose. EU MDR gives more emphasize on PMCF data to confirm the safety and performance of the device throughout its expected lifetime, ensure continued acceptability of identified risks and detect emerging risks based on factual evidence.

MakroCare’s PMCF Capabilities

MakroCare, ISO 14155 certified, is well equipped to support device companies in designing, planning, conducting and reporting of PMCF.

PMCF Strategy / Plan

Development of PMCF strategies based on the device requirements, PMCF plan, study design/type, sample size, evaluation form etc

PMCF Conduct

Implementation of type of PMCF program, data collection as per the PMCF plan and monitoring

Data Analysis

Analysis of data - interim or final to assess the PMCF objectives

PMCF Report

Preparation of interim or final study reports to be included in the clinical evaluation

MakroCare’s Features	Benefits to Manufacturers
TA focused study design team of medical, clinical and biostats experts	Identifying the right PMCF design and type by considering gaps in clinical data
Clinical hypothesis consultation	Developing a PMCF plan and evaluation form objectively based on TA and device requirements
Excellent experience in both prospective and retrospective PMCF program design and conduct	Ensuring scientific validity and acceptability of PMCF data by using the right methodology, sample size calculation and statistical significance
Relevant technology support to ensure seamless data collection for a different type of PMCF	Cost efficiencies in managing the PMCF program through technology integrated approach
Experience teams in PMCF program monitoring, data management, analysis and for writing	Complete end to end program management
Integrated approach using services and technology for PMCF program management