State-of-the-Art (SOTA)

The State-of-the-Art (SOTA) section is considered as one of the most confusing, ambiguous, and challenging parts of a Clinical Evaluation Report (CER).

Contrary to popular believe, SOTA is not about the latest and greatest technological novelties on the regulated market. Instead, it defines the clinical landscape in which the medical device under evaluation is used in order to determine how the safety and performance of the subject device fit in and compare to competitor, similar, and benchmark devices (i.e., comparator devices) as well as alternative treatment options that are available to patients. In other words, SOTA sets the stage that allows for an objective risk-benefit profile assessment of the subject device.

The CER Template contains a pre-populated SOTA section with clear guidelines on identifying, collecting, and organizing relevant clinical and scientific information needed to establish the SOTA of your subject device, as expected by Notified Body (NB) review of CERs in compliance with the EU MDR 2017/745.

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