Mastering the “State of the Art” (SOTA) in Your Clinical Evaluation Report (CER)

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In the complex landscape of the European Union Medical Devices Regulation (MDR) 2017/745, the Clinical Evaluation Report (CER) is often described as the “beating heart” of the Technical Documentation. A pivotal section that dictates the success of this report is the State of the Art (SOTA)..

What Exactly is “State of the Art” (SOTA)?

According to the IMDRF/GRRP WG/N47, the State of the Art represents the developed stage of current technical capability and/or accepted clinical practice regarding products, processes, and patient management. It is based on consolidated findings from science, technology, and real-world experience. In simpler terms, it establishes the clinical benchmark against which your specific device will be measured.

The Two Pillars of a SOTA Section

A well-structured SOTA section generally comprises two essential sub-sections:

Background SOTA: An overview of the current knowledge, standard practices, clinical background, and alternative treatment options within the medical field.
Similar Device Data: This involves reviewing clinical literature and public databases for devices under the same 4th level of EMDN code. This data helps identify clinical benefits, risks, and concerns within the current market.

Defining Safety and Performance (S&P) Acceptance Criteria

The primary objective of analyzing SOTA literature is to define clinically meaningful, evidence-based acceptance criteria for your device’s S&P endpoints. By evaluating outcomes from comparable CE-marked devices, manufacturers can establish:

Complication rates and adverse events.
Efficacy measures.
Upper and lower bounds of clinically acceptable performance.

These quantitative thresholds ensure your device is evaluated against current best practices and real-world expectations rather than in a vacuum.

The Importance of a Robust Literature Search

To satisfy Notified Bodies (NB), manufacturers must conduct at least two separate literature searches: one specifically for the SOTA and another for the Device Under Evaluation (DUE).

The SOTA search provides the benchmark for assessing benefits and risks.
The DUE search focuses on gathering direct evidence for the specific device and its equivalents.

Transparency is key; the search protocol must be scientifically sound, reproducible, and defensible, detailing inclusion/exclusion criteria and search terms to build trust with the NB.

SOTA and the Benefit-Risk Assessment

The SOTA section is not just a theoretical exercise; it is a vital input for the Benefit-Risk Assessment. All clinical data summarized in the CER must be evaluated in the context of the SOTA to determine how the device compares to alternative treatment or diagnostic options. It asks a fundamental question: Are the identified risks acceptable compared to the quantified clinical benefits offered by current technology?

Future Perspectives: Evolving Requirements

Manufacturers should stay informed about potential regulatory shifts. Recent proposals suggest a broader definition of clinical data, potentially allowing the use of non-peer-reviewed scientific literature and even non-clinical testing methods (like computer modeling) to demonstrate safety and performance, provided the approach is thoroughly justified.