Today, let’s talk together about a major pain point in EU clinical evaluation  “the SOTA minefield--SOTA”and hopefully spark some thinking and help fellow practitioners avoid detours:

A note up front:Whenever many teams mention SOTA, two kinds of“vaguewriting”emerge: either they pile up concepts and guidance like a textbook, or they copy every retrieved article into the document like a literature review.

But what reviewersreally want to see is actually more specific:Have you connected“the current treatment/State of the Art”with“the intended purpose and risk profile of your device?”Have you made evidence-based trade-offs? Can what you write support every subsequent clinical evaluation conclusion?

This article has a clear goal:Using less jargon and more practical language, to unpack what MDR + MDCG 2020-13 Section C expects of SOTA and provide an outline, paragraph templates, and a self-checklist you can use directly.

 I. First, let’s make the“regulatory review context”clear:SOTA What exactly is it?

In projects, we often treat SOTA as“the foundation of clinical evaluation”。If the foundation is not laid well, the subsequent equivalence, sufficiency of clinical evidence, and risk-benefit will all become shaky.

In MDR In this context,SOTA is neither a slogan nor a pile of references. It is more like a“map of industry consensus”, answering three types of questions:

1. The current state of the disease and/indication: patient population, care pathway, and unmet clinical needs.

2. The performance level of existing options: drugs, surgery, non-surgical treatment, similar devices, and/alternative devices in terms of effectiveness and safety“can typically achieve.”。

3. The evaluation yardstick: key clinical endpoints (safety and performance endpoint/parameters and Acceptance Criteria), complications,/adverse events, acceptable thresholds, follow-up duration, subgroup differences, and appropriate methods for comparison with standard of care.

   
   

In other words:SOTA it is the reasonable yardstick you set for“how this device should be evaluated”,Clearly define the device's“clinical question statement”，in one sentence: who (the population), in what setting, uses your device to solve what problem, and what it replaces or/supplements.

II.The areas where reviewers SOTA are most likely to“push back”on

We have helped companies handle manySOTAdeficiency letter responses on this topic- NB Review Q&A,SOTA Although the ways in which it is challenged may vary, the underlying logic remains essentially the same and will still center on MDR and MDCGthe applicable regulatory boundary requirements. The depth of questioning may differ among reviewers; a summary is provided below:

1. Is the selected “comparator/ or alternative” recognized by the industry? Has any more commonly used, more advanced, or more relevant option been omitted?

2. Is the claimed effectiveness/ and safety profile supported by data? Are the data sources reliable, and are they applicable to your target population?

3. Is the  SOTA derived “clinical expectation” reasonable? Is the subsequent clinical evidence sufficient to meet this expectation?

4. Has there been any discussion of similar devicethe relevant circumstances?

5. The clinical evaluation does not appear to have been conducted in a methodologically sound, comprehensive, and objective manner, and it does not take into account the generally acknowledged State of the Art

6. The literature review methodology for State of the Art does not appear to be appropriate and does not enable a systematic, comprehensive, objective, and traceable approach

7. Considering the State of the Art, the acceptability criteria for the benefit - -risk ratio of the device under evaluation are not clearly specified in the clinical documentation

8. The clinical documentation does not include specific and measurable safety and performance parameters/objectives，clinical Benefits, Clinical Risk, Benefits-Risk Ratioetc., without considering the current State of the Art.

In our project experience, SOTA the most common “deficiencies ”are summarized as follows:

· Only stating “guideline recommendations”, but not stating “the level of evidence behind those recommendations/ or the key outcome measures”。

· Only stating “that there are many similar devices”, but not clearly explaining the mainstream products, key technology pathways, and points of differentiation.

· Including all of the literature, yet after reading it one still cannot tell “what level is typically achievable in the field”。

· Treating “best-case data” as “the general level”, thereby inflating clinical expectations to an unreasonable extent.

· SOTA and the device's intended population/or use setting are misaligned (for example, using evidence from an inpatient population to justify an outpatient population).

III,A review-defensible State of the Art SOTA, typically includes the following:

3.1 Indications and target population

· Disease definition and staging/grading, and epidemiology (using“order-of-magnitude estimates”is sufficient; there is no need to overload it with data).

· Current diagnostic and treatment pathway: the key steps for patients from diagnosis to treatment.

· Unmet clinical needs: which problems remain inadequately addressed.

3.2 Current standard of care and alternative options

· Drug therapy/Surgery/Conservative treatment/Other devices: present them in“clinical pathway”order.

· For each category, describe the applicable population, main benefits, and main risks/and limitations.

·If there are regional differences (EU/US/local), clearly state the impact of those differences on the assessment.

· The respective advantages and limitations of the current standard of care and alternative options, the level each has reached, and why you seek to demonstrate—or how you will demonstrate—that your device meets the current State of the Art. The underlying regulatory rationale is to assess whether your device lags behind, exceeds, or represents the current State of the Art. The “purpose” of the above key considerations is to evaluate what the device’s “level” brings to patients in terms ofBenefits and Risk/Ratio what exactly???

3.3 Comparable devices and technical approaches

· Mainstream technical principles and key performance characteristics/Structural differences.

· Representative products or categories on the market (no need to prepare a“competitive product report”, but you should show the reviewer that your assessment has been comprehensive).

· Key risk points and failure modes related to the device (to link to the subsequent risk--benefit discussion).

3.4 Clinical outcome measures and acceptable thresholds

· Key effectiveness endpoints:In clinical practice,“what is valued”the most(functional improvement? survival? pain relief? imaging findings?).

· Key safety endpoints: complications,/types, severity, and time window of adverse events.

· Follow-up duration and recurrence/and reintervention: how long is follow-up typically conducted in the field, and why.

· Subgroups and boundary conditions: which populations may have different outcomes, and under which circumstances the risk is higher.

3.5 Based on SOTA of“Clinical Expectations”and Evaluation Strategy

· Turn“the State of the Art”into testable expectations (e.g., the primary endpoint reaches the××range; serious complications are below the××range).

· Explain why these comparators and/benchmarks were selected: guidelines, systematic reviews, real-world data, registry data, etc.

· Lay the groundwork for the subsequent clinical evidence strategy: equivalence, literature-based clinical data,PMCF/clinical investigations, etc.

3.6 Evidence Sources and Search Methods (Concise but Transparent)

· Search scope, time window, databases, inclusion/and exclusion logic (sufficient for the reader to reproduce).

· Evidence hierarchy: guidelines/HTA, systematic reviews, pivotal studies RCT, registry studies, and real-world data.

· Principles for selecting key data: level of evidence/weighting, representativeness, generalizability, and recency.

IV. “Evidence Sources”How to Choose Them Appropriately

Many teams worry:SOTA How much detail should you provide for the sources?Our recommendation is to put “reproducibility” first and “comprehensiveness” second.

The following order of priority is usually the most robust:

· Clinical practice guidelines/ and consensus statements (EU or those relevant to your primary market): used to define the standard of care, endpoints, and clinical pathway.

· HTA/Systematic reviews/Meta: used to characterize the range and heterogeneity of the “prevailing level”.

· Key RCT/ registration studies: used to supplement details, especially safety follow-up windows and subgroup differences.

· Real-world data/ registries (if available): used to verify how the “prevailing level” performs in real-world practice.

· Standards/ and guidance documents (e.g.  ISO, specialty society recommendations): used to supplement risk, performance, and conditions of use.

In terms of writing technique, we recommend“being selective, concise, and precise”: use the evidence that most strongly supports your conclusion as the core citations, and treat the rest as supplementary support. This allows the reviewer to read more efficiently and makes traceability easier.

5.Reviewer-friendly“paragraph drafting”

The following is not a templated slogan, but a“review-ready narrative structure”. You may replace the bracketed content.

• For[the indicated/patient population]:

• current clinical practice generally follows[an overview of the clinical management pathway]：

• first-line/standard treatment mainly includes[regimensA/B/C]：

• with the key benefits reflected in[key effectiveness endpoints]：

• within[the follow-up period]typically reaching[the expected range/or magnitude]：

• the main risks are concentrated in[key complications], most commonly occurring within the[time window], with incidence generally in the[range]：

• For[specific subgroups/boundary conditions], due to[factors], effectiveness/and risk profiles may differ; therefore, they require particular attention in the clinical evaluation[endpoints/follow-up/risk control]：
  
  Based on the above generally accepted State of the Art, we define the clinical expectations for this device as[verifiable expectations], and select[comparator/benchmark]as the evaluation yardstick. This will be used to support the subsequent[equivalence/literature evaluation/PMCF/Clinical Trials]Strategy.

  
  

VI. NB Common Review Deficiency Checklist (Before Deliverychecklist）

□ SOTA Does it cover all major alternatives? Does it explain why certain options were not selected as the primary comparator?

□ Are the endpoints aligned with the guidance/and clinical practice? Is there“a risk of selecting uncommon endpoints”?

□ “the general level”Is a range/or conditional expression used instead of a single-point optimal value?

□ Does the evidence apply to your target population and intended use scenario? Is there an extrapolation risk?

□ Have the time window and severity of key safety risks been identified and presented?

□ SOTA Are the clinical expectations clearly derived and tied back to the evidence strategy that follows?

□ Are the search and evidence selection processes transparent and reproducible? Are the time window and inclusion logic explained?

□ Is the document internally consistent: do the population, indication, comparator, endpoints, and follow-up duration all align?

Reference

[1] Regulation (EU) 2017/745 on medical devices (MDR)

[2] MDCG 2020-13: Clinical Evaluation Assessment Report (CEAR) template

[3] MEDDEV 2.7/1 rev. 4: Clinical Evaluation – A guide for manufacturers and notified bodies