PMCF defined as a continuous process that are updated in clinical evaluation the manufacturer is expected to proactively collect and evaluate clinical data from use in or on humans of a device or It is a study is the practice and following up with clinics, hospitals and other medical facilities on the safety and performance of medical device.
The most common PMCF activities are:
- PMCF Survey: PMCF surveys a valid method of collecting post-market clinical data. They can be used to gain information on a device and its use from both healthcare professionals and patients by providing a set of questions to be answered.
- PMCF Case series: PMCF Case series is a simple data collection activity that includes a series of cases or patients. For years, device manufacturers and device.
- PMCF studies are one of several options available in a post-market surveillance program and contribute to the risk management process.
- Literature and published research screening of scientific literature to collect information on clinical safety and performance.
The PMCF Studies is conducted on medical devices that are already CE Mark certified. It is under annex XIV-part B.
- The PMCF Studies is conducted on medical devices that are already CE Mark certified. It is under annex XIV-part B.
- The general methods and procedures of the PMCF to be applied such as gathering of clinical experience, gained, feedback from users, screening of scientific literature.
- The specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies
- The specific objectives to be addressed by the PMCF
- An evaluation of the clinical data relating to equivalent or similar devices.
Objectives:
- PMCF plans should be designed to product real world evidence on your devices safety and performance under normal use.
- Longitudinal data collection providing evidence on the safety and performance for the life time of the product.
Scope:
It is intended to provide the guidance on the design, implementation and appropriate use of PMCF studies.
Circumstances where PMCF may be indicated:
When considering the overall benefit and risk of a device for marketing authorization, uncertainties may remain regarding the extent of potential benefits and residual risks of the device.
PMCF studies can be used to collect additional clinical data to address the remaining uncertainties about a device.
Conclusion:
The study should be executed according to the PMCF study plan, and the collected data should be analyzed and interpreted.
