Clinical Evaluation Report documentation expected from the date of CE Certification. This means PMCF and PMS start in the same period.
Is the clinical evaluation updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer’s PMCF plan and PMS plan?
4 thoughts on “Clinical Evaluation and Life Cycle of the Device”
The initial clinical evaluation, that is, the clinical evaluation performed during the development of the product or before a product’s release to the market, does not require clinical data obtained from PMS or PMCF. Clinical data can be obtained from the literature of equivalent or similar device or from Clinical Investigation itself.
Answer to the question is Yes, once the product has been released to the market after CE certification, the manufacturer should maintain a PMS system as per the QMS or the requirement of the legislation and thus, the update of the clinical evaluation should be concerned with clinical data obtained from the execution of the manufacturer’s PMS and PMCF plan, throughout that product’s lifecycle. This clinical data could be the data from literature of the subject device itself, equivalent or similar device, PMCF studies of subject device, etc.
Yes, the clinical evaluation need to be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer’s PMCF plan and PM Plan
PMS system is implemented from manufacturers maintain the PMS plan that routinely monitors the clinical performance and clinical safety of the device
New data is generated regularly from PMS (for e.g. results from published literature, safety reports, PMCF studies, registries and other data about usage of the device). The above data is required to be evaluated for information that has a potential to change the evaluation of the risk/benefit profile and the clinical performance and clinical safety of the device. Those data are required to be included into the clinical evaluation process in a timely manner.
Clinical Evaluation is done for conformity assessment of the device that gives the authorization to place the device in market. But it is important to monitor the performance of the device after it is released into the market, as some risks will be identified only after regular usage, storage, transportation and cleaning of the device during its practical usage. So the manufacturers shall plan and implement proper PMS and PMCF procedures for proactively collecting and evaluating clinical data in order to confirm the safety and performance of device throughout its expected lifetime. With this the problems with the design, manufacture or use of medical devices can be identified and necessary CAPA can be taken without delay.
Yes, Clinical evaluation needs to be updated throughout the life cycle of the medical device.
For devices under development, it is updated with the clinical data obtained from literature search of the similar devices, equivalent devices and subject device’s information provided by manufacturer (pre-clinical data, IFU, labels etc).
For devices in market, CER will be updated with information regarding any additional risks, residual risks and side effects during its usage, storage and transportation received from PMS or PMCF activities following respective plans with FSCA and CAPA taken into consideration.