State of the Art (SOTA) is the developed stage of current technical capability and accepted clinical practice for a given device type, drawn from consolidated findings of science, technology, and experience. Under EU MDR and IVDR, it means the generally accepted good practice for a device, not the newest or most advanced technology available.
What is State of the Art (SOTA)?
State of the Art (SOTA), also written SoA, is a regulatory benchmark that asks one question: what is currently accepted as good practice for this kind of device? It is defined in ISO 14971:2019 (Clause 3.28) as the developed state of technical capability at a given time, based on consolidated findings of science, technology, and experience. A note to that clause is the part teams misread most often. It states that the state of the art does not necessarily imply the most technologically advanced solution.
The EU MDR (Regulation 2017/745) and IVDR (Regulation 2017/746) reference the “generally acknowledged state of the art” repeatedly but give no formal definition of their own. For practical wording, manufacturers turn to MDCG 2020-6, which frames it as the developed stage of current technical capability and accepted clinical practice for products, processes, and patient management. The concept earlier took shape in IMDRF/GRRP WG/N47:2018.
Why State of the Art (SOTA) matters in medical device development
State of the art is a compliance obligation, not a marketing phrase. GSPR 1 in Annex I of the MDR requires that any residual risks remain acceptable when weighed against the benefits, taking the generally acknowledged state of the art into account. A Notified Body reviewing your technical documentation will check that your risk controls, performance claims, and clinical evidence reflect what peers consider good practice today.
Getting this wrong has direct consequences. If a safer design, a recognized standard, or a better-established alternative therapy exists and your file ignores it, the benefit-risk argument weakens, and the submission can stall. State-of-the-art also moves. A control acceptable at first certification can fall behind when a new standard edition is published, or clinical practice shifts, so post-market surveillance keeps revisiting it.
How State of the Art (SOTA) is established
There is no single document that hands you the state of the art. You assemble it, then defend it. A workable approach:
Define the scope
Fix the intended purpose, device type, indication, and target population so the benchmark stays specific rather than generic.
Gather the inputs
Pull applicable standards (for example, ISO 14971, IEC 60601-1, IEC 62304), regulatory guidance, peer-reviewed literature, clinical practice guidelines, and information on alternative devices and treatments.
Benchmark against alternatives
Compare your device with established options for the same clinical need, including non-device therapies where relevant.
Document the conclusion
Record the state of the art in the Clinical Evaluation Report (CER) and the ISO 14971 risk management file, with traceable sources.
Keep it current
Reassess through post-market surveillance and periodic literature review, then feed changes back into risk controls and the CER.
ISO/TR 24971:2020 gives guidance on applying ISO 14971 to this work, and the harmonized EN ISO 14971:2019/A11:2021 links it to the MDR and IVDR. For clinical evaluation, MDR Annex XIV and MEDDEV 2.7/1 Rev 4 both expect a documented state-of-the-art section.
Common challenges and best practices
The most common error is treating state of the art as a synonym for the newest technology. Regulators mean the accepted middle ground of proven, available practice, not experimental work still in trials. A device need not be the most advanced on the market, only at least as safe and effective as what is generally accepted.
A second trap is treating it as a one-time exercise written at certification and never reopened. Build a recurring trigger into your PMS plan so new standard editions, safety signals, and literature get reviewed on a defined cadence. Thin literature searches are a third weakness; an undocumented or unsystematic search rarely survives review. Good practice ties the state-of-the-art conclusion directly to risk acceptability criteria and to specific performance claims, so the thread from evidence to decision is easy to audit.
How SJML helps with State of the Art (SOTA)
SJML supports state-of-the-art work as part of its Compliance-as-a-Service offering. Our QARA and clinical teams build clinical evaluation plans and reports, run systematic literature reviews, and maintain ISO 14971 risk management files so the state-of-the-art conclusion is documented and traceable to its sources. We also set up post-market surveillance and PMCF planning that revisits the benchmark over the device lifecycle, keeping technical documentation aligned with current standards and accepted clinical practice for EU MDR and IVDR.
Frequently asked questions
No. In the medical device context, state of the art means what is currently and generally accepted as good practice for a device type, based on consolidated science, technology, and experience. ISO 14971:2019 states plainly that it does not necessarily imply the most technologically advanced solution. The benchmark is proven, available practice, not experimental technology still in development.
The “generally acknowledged state of the art” appears across the General Safety and Performance Requirements in Annex I of the MDR, starting with GSPR 1 on benefit-risk acceptability. It also underpins clinical evaluation under Annex XIV and risk management aligned with ISO 14971. Manufacturers must show that design, risk controls, and clinical evidence reflect it.
There is no fixed interval in the regulation, but state of the art is not a one-time task. It should be revisited through post-market surveillance whenever a new standard edition, safety signal, or relevant clinical publication appears, and at the planned review points in the PMS and clinical evaluation cycle. Many manufacturers reassess at least annually for higher-risk devices.
The latest technology is whatever is newest, including prototypes and devices in clinical trials. State of the art is the established, generally accepted practice already in routine use for a given clinical need. A brand-new device can be the latest technology without yet being state of the art, and a mature device can remain state of the art for years.
Related terms
- Clinical Evaluation Report (CER)
- Risk Management (ISO 14971)
- General Safety and Performance Requirements (GSPR)
- Post-Market Surveillance (PMS)
- Benefit-Risk Determination
