A Whitepaper on Best Practices and Compliance
Executive Summary
State-of-the-Art (SOTA) is a cornerstone concept within the EU Medical Device Regulation (MDR) 2017/745. Although the regulation does not define the term explicitly, it is referenced extensively in guidance documents and regulatory assessments. SOTA serves as the benchmark for technological, clinical, and risk management expectations in the EU market. This whitepaper provides a comprehensive overview of how manufacturers can demonstrate compliance with SOTA under MDR, including key regulatory references, best practices, and actionable compliance strategies.
1. Introduction
Under MDR 2017/745, “State-of-the-Art” transcends the notion of merely adopting the latest technology. It refers to aligning medical devices with the most widely accepted scientific, technical, and clinical standards. This whitepaper explores how SOTA is critical for ensuring device safety, performance, and marketability, and provides guidance for manufacturers to integrate SOTA principles throughout the product lifecycle—from design to post-market surveillance.
2. Understanding the Concept and Importance of SOTA
What is “State of the Art”?
According to the IMDRF (IMDRF/GRRP WG/N47 FINAL:2024, Edition 2), state-of-the-art is defined as:
“Developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.”
In regulatory terms, this represents the current best practices in safety, performance, and risk mitigation. It is not necessarily synonymous with the most recent innovation, but rather what is proven, accepted, and adopted within the industry.
Why It Matters
MDR 2017/745 requires that all medical devices demonstrate compliance with the current state of the art in terms of design, risk control, and clinical performance. This includes:
- Comparing device performance against current alternatives.
- Updating documentation as standards evolve.
- Justifying any deviation from generally accepted practices.
Failing to demonstrate alignment with SOTA can jeopardize CE certification and market access.
3. Key SOTA Compliance Elements Under MDR
To align with MDR expectations, manufacturers must address SOTA across several critical domains:
Risk Management
- Follow ISO 14971 for risk management.
- Use up-to-date literature and standards to justify risk control measures.
- Ensure documentation is traceable and evidence-based.
Standards Compliance
- Adhere to the latest harmonized or internationally recognized standards.
- Maintain a regulatory watch process to track changes.
- Use a standards mapping table to link test methods with current standards.
Clinical Evaluation and the SOTA Section
- Include a dedicated SOTA section in the Clinical Evaluation Report (CER).
- Conduct systematic literature reviews.
- Compare your device against the standard of care and similar marketed devices.
- Reference clinical guidelines, DOIs, and peer-reviewed sources.
Technical Documentation
- Demonstrate SOTA integration across design, manufacturing, clinical, and PMS documentation.
- Use traceable references and maintain version control.
Post-Market Surveillance (PMS)
- Establish a proactive PMS and PMCF plan.
- Use PSURs to confirm continued SOTA compliance.
- Incorporate emerging evidence into updates of the CER, RMF, and technical files.
4. Do’s and Don’ts for SOTA Compliance
✅ Do:
- Conduct comprehensive state-of-the-art reviews early in development.
- Use the latest harmonized standards and update regularly.
- Benchmark performance against leading alternatives.
- Document and justify all risk control measures with SOTA evidence.
- Maintain living documents with scheduled updates.
❌ Don’t:
- Equate “new” with “state-of-the-art” without evidence.
- Use outdated studies, standards, or competitor data.
- Omit rationales for deviations from best practices.
- Rely on a passive approach—SOTA requires active monitoring and updating.
5. Regulatory References to “State-of-the-Art” in MDR 2017/745
The MDR explicitly references SOTA in several key areas. Here are a few examples:
- Article 1(2) – Non-medical purpose devices must adhere to SOTA in risk management and clinical safety.
- Article 62(4)(l) – Even investigational devices must take SOTA into account for safety testing.
- Annex I, GSPR 2 & 4 – Safety and performance must align with generally acknowledged SOTA.
- Annex I, GSPR 17.2 – Software must be developed and validated in accordance with the state of the art.
- Annex IX, Section 2.1 – The clinical evaluation plan must be kept current with SOTA.
- Annex XIV & XV – Clinical investigations and evaluations must include a detailed review of SOTA and justify benefit–risk ratios accordingly.
These references underscore the regulatory imperative to treat SOTA as a dynamic benchmark, not a one-time certification step.
Conclusion
“State-of-the-Art” is not a static designation but a continuously evolving benchmark. Under MDR 2017/745, manufacturers must demonstrate that their devices are designed, evaluated, and updated in line with the most current scientific knowledge and regulatory standards. This requires robust systems for literature review, standards tracking, post-market monitoring, and documentation management.
SOTA is both a foundation and a challenge: it ensures high standards for safety and performance while demanding continual vigilance and adaptation from manufacturers.
References
- EU MDR 2017/745
- IMDRF/GRRP WG/N47 FINAL:2024 (Edition 2)
