Post-Market Clinical Follow-Up Studies for Medical Devices
PMCF studies are not intended to replace the premarket data necessary for market authorization. While clinical evidence is an essential element of the premarket conformity assessment process to demonstrate conformity to Essential Principles.
Elements of PMCF study
PMCF studies are performed on a device within its intended use/purpose(s) according to the instructions for use.
- Clearly stated objective(s).
- Scientifically sound study design with an appropriate rationale and statistical analysis methods summarized in a study plan.
- Implementation of the study according to the plan.
