To conduct the appraisal and analysis of the clinical data of the device or the equivalent device manufacturer need to review current knowledge and or state of art.
State of the art in the relevant medical field refers to current knowledge, such as applicable standards and guidance documents, information about the medical condition managed by the device and its natural course, benchmark devices, or other devices and medical alternatives available to the target population. Manufacturers and Notified Bodies can use the state-of-the-art description to evaluate the device’s safety and performance.
The clinical background must include a full explanation of the medical disease to be treated, its natural course and implications, and how it will be managed or diagnosed using the investigational device.
The prevalence of medical disorders in the general population, which varies by age group, gender, ethnicity, familial predispositions, and genetic features, must be covered, and information regarding the various clinical forms, phases, and severities of the medical condition. Data on treatment, management, or diagnostic choices for medical disorders should be explained in historical context and advances, reviewing the pros and downsides of the many alternatives available.
Benefits/risk profiles and restrictions with different clinical forms, phases, and severities of specified medical problems and other target populations. The benefits and hazards, including the kind, extent, likelihood, duration, and frequency, must be clearly defined, as well as the acceptability of unwanted side effects, causes of damage, clinical elements of side effect reduction and management, and other risks.