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5 min read
State of the Art (SOTA) is a critical yet frequently misunderstood component of Clinical Evaluation Reports (CERs) under the EU Medical Device Regulation 2017/745. Although MDR requires consideration of generally acknowledged SOTA, it does not provide a prescriptive definition, leading Notified Bodies to closely scrutinize how SOTA is defined, justified and applied when assessing safety, performance and benefit–risk conclusions.
Experience from MDR audits shows that generic or outdated SOTA descriptions are a common source of findings, particularly when used to justify equivalence, evidence sufficiency or the absence of clinical investigations. Consequently, the ability to clearly define and apply SOTA within a robust clinical evaluation framework has become essential for EU MDR compliance.
Why SOTA Matters in Clinical Evaluation Under MDR
State of the Art (SOTA) under the EU MDR functions as a regulatory benchmark rather than a descriptive concept. Notified Bodies expect manufacturers to demonstrate that their device meets or exceeds current clinical practice, based on existing technologies, medical knowledge and available alternatives. This expectation runs through requirements for clinical evaluation under EU MDR, risk management and benefit-risk analysis. MDCG guidance emphasises that SOTA must reflect current practice rather than outdated norms to support defensible conclusions.
Common Misinterpretations of State of the Art
Most frequent challenges in CER is the misinterpretation of what SOTA represents under the EU MDR. Notified Bodies often question SOTA sections that rely on standards, limited competitor comparisons or broad literature reviews without clear clinical relevance.
SOTA is not defined by:
- Minimum regulatory requirements
- The manufacturer’s legacy device portfolio
- A narrow selection of competitor products
Instead, SOTA represents the current level of clinical practice, shaped by scientific evidence, established clinical guidelines and real-world outcomes. This distinction is essential for setting robust performance benchmarks and justifying residual risks in clinical evaluation.
Regulatory Expectations for Defining SOTA
Although the MDR does not explicitly define SOTA, regulatory expectations are well established through authoritative guidance. MEDDEV 2.7/1 Revision 4 – Clinical Evaluation continues to shape Notified Body assessments by stressing the need to evaluate devices in comparison with current clinical practice and available alternative solutions.
Similarly, MDCG 2020-6 emphasises contextualising clinical evidence against contemporary benchmarks to support benefit–risk and performance assessments. Collectively, these sources make it clear that SOTA must be clinically relevant, evidence-based and transparently justified within the clinical evaluation report.
A Practical Framework for Establishing SOTA in CERs
A robust SOTA framework in CERs starts with precisely defining the medical condition, intended use and clinical claims. Manufacturers must identify all clinically accepted treatment options, including comparable devices, benchmark products and non-device alternatives. This broad scope ensure, SOTA reflects current standard of care, offering clear benchmarks for safety, performance and benefit–risk, reducing common Notified Body deficiencies.
Clinical literature plays a central role in this process. Systematic identification and appraisal of peer-reviewed studies, clinical guidelines, and consensus statements help determine what outcomes, safety profiles and performance levels are considered acceptable in current practice. Well-structured medical device literature search protocols and critical reviews are therefore foundational to credible SOTA definitions.
Using SOTA to Benchmark Safety and Clinical Performance
Once SOTA is established, it must be actively applied within the clinical evaluation report. Notified Bodies expect manufacturers to explain how their device compares to SOTA in terms of safety outcomes, clinical benefits and known risks.
This comparison should be explicit rather than implied. Performance claims, equivalence arguments and benefit–risk conclusions should all be grounded in the defined SOTA framework. Where a device does not outperform SOTA, the CER should clearly demonstrate that it meets current clinical expectations and explain why any observed differences do not adversely affect patient safety or clinical benefit.
This level of transparency is central to robust clinical evaluation of medical devices and reduces ambiguity during Notified Body assessment.
SOTA, Article 61, and Evidence Sufficiency
SOTA plays a critical role in demonstrating sufficient clinical evidence under Article 61 of the MDR. When manufacturers rely on literature, equivalence, or post-market data, Notified Bodies assess whether the evidence is adequate in light of current SOTA.
If the defined SOTA has advanced beyond the evidence base used in the CER, Notified Bodies may question the sufficiency of clinical data even for long-marketed devices. This makes SOTA a dynamic reference point rather than a static description, reinforcing the need for periodic reassessment as part of ongoing clinical evaluation updates.
Lifecycle Considerations and SOTA Maintenance
State of the art is not fixed at the time of certification. As new therapies emerge, standards evolve or clinical guidelines change, SOTA expectations may shift. Notified Bodies increasingly expect manufacturers to demonstrate awareness of these changes and assess their impact on existing clinical evaluations.
Integrating SOTA monitoring into medical device lifecycle management ensures CERs remain aligned with current clinical knowledge. This is particularly important for PMS, PMCF and PSUR updates, where emerging safety or performance data may alter the SOTA landscape.
SOTA Challenges for SaMD and AI-Based Devices
Defining SOTA is especially complex for Software as a Medical Device (SaMD) and AI-based technologies, where clinical practice and technological capabilities evolve rapidly. In these cases, SOTA may be informed by algorithm performance benchmarks, clinical validation studies and real-world use data rather than traditional device comparators.
Regulatory expectations in this area are increasingly shaped by IMDRF guidance on Software as a Medical Device (SaMD) and broader perspectives from European Medicines Agency (EMA) on digital health and artificial intelligence. Manufacturers must clearly explain how SOTA is defined in this evolving context and ongoing updates are managed.
Conclusion: Strengthening CERs Through Defensible SOTA
Under EU MDR, SOTA is a critical benchmark for assessing safety, clinical performance and benefit–risk acceptability. Notified Bodies expect SOTA to be clearly defined, evidence-based and actively applied within the CER.
Considering SOTA as a dynamic, clinically grounded benchmark helps manufacturers defend their clinical evidence and withstand regulatory scrutiny. A structured SOTA framework strengthens CER credibility and supports long-term compliance as clinical practice evolves.
How Freyr Supports SOTA in Clinical Evaluation
Establishing and maintaining a defensible SOTA framework requires deep clinical insight, regulatory expertise and structured evidence appraisal. Freyr supports manufacturers in defining SOTA aligned with current clinical practice, integrating literature-based benchmarks into CERs and addressing notified Body questions related to safety and performance comparisons.
Freyr’s experts help ensure that SOTA remain current, transparent, and aligned with Article 61 expectations across the device lifecycle. For support with SOTA, clinical evaluation strategy or CER remediation under EU MDR, speak to a Freyr experts to discuss your specific regulatory challenges.
