State of the Art
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.
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?