State of the Art Medical Devices
State of the Art of Medical device is the developed and evolution of the technology used behind working of the device. As per the MDR and the IVDR, we must demonstrate the thorough analysis of the state of the art. It is an important section in the CER and must consider only the developed devices sold on the market with the CE marking for this analysis.
State of the Art is critical in the risk management for performing the risk benefit ratio. For example if there are two devices in the market that are technically advances and lesser risk than our medical device (which is well established in the market for long), then the former two will reduce the benefit of our device and increase our device risk side. Hence the state of the art is the current knowledge in the respective medical field. In the IVDR, the level of the clinical evidence must be demonstrated on the basis of the state of the art.
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In a clinical evaluation of medical device, how can we describe a state of the art? What are sections in the Technical documentation we are to present the analysis of the state of the art? Is the previous generation and similar generations of the medical device having to be considered in the state of the art?
In a clinical evaluation, SOTA comprises of applicable standards, guidance documents, medical fields concerned and data related to benchmark devices and medical alternatives available to specific medical conditions and patient population engaged with device under evaluation. This helps to identify the clinical background and current knowledge in respective medical field as well as risks and side effects associated with the intended medical field and purpose of device.
Acceptability of Risk Benefit Profile and Clinical Data (for all medical conditions covered by the intended purpose when compared with the clinical background, current state of the art in the corresponding medical field considering limitations if any) are the sections in Technical documentation considered for analysis of state of the art.
Yes, the previous generation and similar generations of the medical device can be considered in the state of the art which serves the purpose of clinical background, current knowledge and alternatives available to medical device.