Clinical Investigation and Post Market Clinical Follow Up along with Post Market Surveillance should be planned, established, documented, implemented, maintained and updated for each medical device after it has been commercialized. It should be considered the device type and risk class. The PMS should be integrated in the company’s Quality Management System and should be built together and analyze the data on quality, performance and safety of the device throughout its entire life cycle. It should also be allowed to draw conclusions about this data and be linked into the company’s preventive and corrective action system.
The data and conclusions derived from the PMCF study are used to providing clinical evidence for the clinical evaluation in line with PMS planning.
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If the clinical investigation is excepted then, is the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device?
PMCF (Post- market clinical Follow- up) is a continued process of collecting and updating the clinical data of the medical device after it is released in market.
Manufacturer’s PMS plan shall incorporate PMCF plan. In some cases PMCF studies are conducted as per plan. The plan should justify the objective, design, nature and duration to confirm the safety and performance of the device throughout the expected lifetime and to ensure acceptability /suitability of identified risks (residual risk) and also to detect any new risks.
Clinical investigation studies can be often replaced with well-designed post market
Surveillance and PMCF presuming such consent is approved following discussion with the responsible notified body. Upon request the PMCF report can be submitted to the relevant notified body for review.
I agree with the responder. At times, especially in the case of implantable devices and class III devices, the clinical investigations can be exempted if the NB approves the PMCF plan that includes well-designed PMS studies with the objective to confirm with relevant safety and performance requirements.
For class III and implantable devices exemption from clinical investigation is possible, if the device is modification of an equivalent device manufactured by same manufacturer and the clinical evaluation of that equivalent device is adequate to prove the safety and performance of device under evaluation. In such a case, clinical investigation can be replaced by a well designed post market clinical follow up plan which also includes post market studies in order to prove the safety and performance of device. This shall be done after taking approval from the notified body.
PMCF is an ongoing process throughout the lifecycle of the device to update the CER following collection and evaluation of post market clinical data to confirm the safety and performance of the device, ensures continued acceptability of the risk-benefit ratio, identify earlier unknown risks and side effects, in absence of clinical investigation and it shall be part of manufacturer’s PMS plan with approval from notified body.