State of the art (SOTA) for a medical device: how to build it
7 Min Read
Methodology
What the state of the art is for in an MDR clinical evaluation, which sources to use and how to structure the literature review that documents it.
By Bopha Suybeng, PharmD, founder of NOÉ. Twelve years of experience in the clinical evaluation of medical devices.
In short: the state of the art (SOTA) describes what medicine currently knows and does for a given condition. In an MDR file, it is the benchmark used to judge whether a device's performance, safety and benefit-risk ratio are acceptable. It is documented through a dedicated literature review, with its own protocol.
Why the MDR requires a state of the art
Regulation (EU) 2017/745 refers to the generally acknowledged state of the art in the general safety and performance requirements (Annex I) and in the clinical evaluation requirements (Annex XIV, Part A). In practice, a notified body cannot conclude that a device is safe and performs as intended without knowing what to compare it with.
What the SOTA is for in the clinical evaluation report
Describe the condition, its current management and the treatment options, including alternatives that are not devices.
Define the relevant performance and safety outcomes, and the acceptance thresholds.
Identify the known risks of comparable devices.
Position the claimed clinical benefit against the alternatives.
Which sources to use
Clinical practice guidelines and positions of learned societies.
Recent systematic reviews and meta-analyses.
Applicable harmonised standards and common specifications.
Registries and large clinical series.
Public vigilance data on similar devices.
A review separate from the device review
The state-of-the-art search answers a different question from the search on the device under evaluation. It covers the condition and all treatment options, not one product. It is therefore better to give it its own protocol: questions, databases searched, search strings, inclusion and exclusion criteria. This separation makes the approach clearer for the notified body and prevents a device-focused search from missing the alternatives.
How to structure the SOTA section
The medical condition: definition, epidemiology, natural course.
Current management and treatment alternatives.
Comparable devices and their published results.
The performance and safety outcomes retained, with their thresholds.
The conclusions used to judge the device under evaluation.
Common mistakes
A SOTA written as a general introduction, with no usable quantified criteria.
Outdated sources, with no justification for the period covered.
Leaving out non-surgical or drug alternatives.
A non-reproducible search, with no search strings or dates.
A state of the art never updated while practice evolves.
Where a tool like NOÉ comes in
A state-of-the-art review often covers a large corpus. NOÉ applies the same eligibility criteria to every article, keeps the justification for each inclusion and exclusion, produces the PRISMA flow diagram and structures data extraction. The evaluator remains in charge of the analysis and conclusions.
