--- title: The State of the Art Principle in MDR: What It Means for Your Design Decisions description: What 'state of the art' means under EU MDR, how it affects medical device design, and how startups can demonstrate they meet this critical requirement. authors: Tibor Zechmeister, Felix Lenhard category: MDR Fundamentals & Regulatory Strategy primary_keyword: canonical_url: https://zechmeister-solutions.com/en/blog/state-of-the-art-principle-mdr-design-decisions source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # The State of the Art Principle in MDR: What It Means for Your Design Decisions *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* "State of the art" is one of those regulatory phrases that sounds intuitive until you try to apply it. Everyone agrees that medical devices should reflect the state of the art. Nobody agrees on exactly what that means in practice, how to demonstrate it, or where the line is between "state of the art" and "nice to have." Yet the state of the art principle is embedded throughout MDR and directly affects your design decisions, your risk management, and your clinical evaluation. Getting it wrong can lead to Notified Body findings, market surveillance actions, or — worst case — unsafe devices reaching patients. ## Where MDR References State of the Art MDR Annex I, Chapter I, Section 1 states that devices shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users. Risks must be reduced as far as possible without adversely affecting the benefit-risk ratio, and risk reduction measures must take account of the **generally acknowledged state of the art**. The concept appears in several GSPR contexts: - **Risk reduction:** Risks must be reduced taking into account the generally acknowledged state of the art - **Design and manufacture:** Devices must be designed and manufactured reflecting the state of the art in terms of safety - **Clinical evaluation:** The clinical evaluation must consider the state of the art in the relevant medical field ## What "State of the Art" Actually Means The state of the art is not the same as "the latest technology." It is not about using the newest chip, the fanciest algorithm, or the most advanced manufacturing technique. The concept is broader and more nuanced. **State of the art** refers to the 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. This definition aligns with how the concept is understood in European product safety law and in ISO/IEC standards. In practical terms, state of the art means: 1. **What is technically feasible today** — the current level of technology that is available and proven 2. **What is recognized as best practice** — approaches that the scientific and technical community acknowledges as appropriate 3. **What is documented in standards and scientific literature** — the consolidated knowledge base in the relevant field 4. **What is achievable without disproportionate effort** — state of the art does not require the impossible or the economically unreasonable, but it does require genuine effort to apply current knowledge ### What State of the Art Is NOT - **Not the absolute cutting edge.** A research prototype published last week is not yet "state of the art." State of the art refers to established, proven capabilities — not bleeding-edge innovations. - **Not the most expensive option.** State of the art does not require gold-plating. It requires applying proven technology and knowledge appropriately. - **Not frozen in time.** State of the art evolves. What was state of the art when you designed your device five years ago may not be state of the art today. This has implications for device lifecycle management. - **Not defined by a single standard.** Harmonized standards represent a significant component of the state of the art, but they are not the complete picture. Standards lag behind technical development — the state of the art can include knowledge not yet codified in standards. Tibor frames it practically: "State of the art is the answer to the question: what would a competent manufacturer, with access to current knowledge and technology, do in this situation? It is not perfection. It is competence applied with current tools and knowledge." ## How State of the Art Affects Your Design Decisions ### Risk Management ISO 14971 requires you to consider risk reduction measures, and MDR requires those measures to take account of the state of the art. In practice, this means: When you evaluate risk control options, you cannot ignore available solutions just because they cost more or require more development effort. If a state-of-the-art risk control measure exists that would reduce risk, you must either implement it or justify why you did not. **Example:** If your device uses a lithium battery and the state of the art includes specific battery management system designs that prevent thermal runaway, your risk analysis must consider those designs. If you choose a simpler battery management approach, you need to justify why — perhaps the simpler approach achieves equivalent safety for your specific use case. **Example:** If your software processes patient data and the state of the art in cybersecurity includes specific encryption and authentication approaches, your risk analysis must consider them. Ignoring current cybersecurity practices because "we are a small startup" is not an acceptable justification. ### Material Selection For devices that contact the body, material selection must reflect the state of the art in biocompatibility. This means using materials with established biocompatibility profiles, applying current testing methodologies (ISO 10993 series), and considering emerging concerns about specific materials (such as evolving understanding of particulate matter from certain polymers). ### Software Design For software medical devices, the state of the art is evolving rapidly. Areas where state of the art expectations are particularly relevant: - **AI/ML algorithms:** If you use machine learning, the state of the art in validation, bias detection, and performance monitoring is relevant - **Cybersecurity:** The state of the art in medical device cybersecurity is defined by standards like IEC 81001-5-1 and evolving guidance - **Interoperability:** The state of the art in health data interoperability (HL7 FHIR, IHE profiles) may be relevant depending on your device's integration requirements ### Manufacturing Processes Manufacturing methods must reflect the state of the art for producing safe, consistent medical devices. For 3D printing, this means validated processes, material characterization, and process controls that reflect current knowledge. For traditional manufacturing, it means current process validation approaches. ## How to Demonstrate State of the Art in Your Documentation Your technical documentation must demonstrate that your device reflects the state of the art. Here is how to build that evidence: ### 1. Literature Review Conduct a systematic review of scientific and technical literature in your device's field. Identify current practices, current technologies, and current safety approaches. This review can be integrated into your clinical evaluation's literature search or conducted separately as part of your design justification. ### 2. Standards Application Applying current harmonized standards is one of the strongest demonstrations of state of the art. Standards, by definition, codify established good practice. If your device complies with current harmonized standards, you have strong evidence that your design reflects the state of the art covered by those standards. ### 3. Competitor and Market Analysis Understanding what other devices on the market do — their features, their safety measures, their performance — provides context for the state of the art. You do not need to copy competitors, but you should be aware of what the market considers standard practice. This analysis does not need to be a formal competitive intelligence report. It can be a documented review of publicly available information (IFUs, published clinical data, EUDAMED entries) for similar devices. ### 4. Expert Input For novel device types or rapidly evolving fields, expert input can help establish what the state of the art is. If you have clinical advisors, regulatory consultants, or technical experts, their documented opinions on current best practices are relevant evidence. ### 5. Risk Management Documentation Your risk management file should explicitly reference the state of the art when evaluating risk control options. For each identified risk, the analysis should consider what state-of-the-art measures are available for risk reduction. ## The State of the Art and Clinical Evaluation Your clinical evaluation must be conducted in the context of the state of the art in the relevant medical field. This means: - **Identifying the current clinical standard of care** for the condition your device addresses - **Comparing your device's performance and safety** to currently available alternatives (including other devices and non-device treatments) - **Demonstrating that your device's benefit-risk profile** is acceptable in the context of current treatment options A clinical evaluation that ignores developments in the field — new treatment approaches, new safety data, new performance benchmarks — fails to reflect the state of the art. ## The Lifecycle Dimension State of the art is not a snapshot — it evolves over time. Your obligations do not end at certification: **Post-market surveillance** must include monitoring the state of the art. If the state of the art in your device's field advances significantly — through new safety data, new treatment alternatives, new technological capabilities — you may need to update your device, your risk analysis, or your clinical evaluation. **Clinical evaluation updates** (required periodically by MDR) must reflect the current state of the art at the time of the update, not the state of the art at the time of original certification. **Notified Body surveillance audits** may include assessment of whether your device continues to reflect the state of the art. This creates an ongoing obligation. Tibor's advice: "Build state-of-the-art monitoring into your post-market surveillance process. It does not need to be a huge effort — a periodic literature review, a check on competitors and market developments, a review of new or revised standards. But it must be systematic and documented." ## What Happens When You Fall Behind If your device no longer reflects the state of the art: - **Notified Body findings.** During surveillance audits, the NB may find that your device or its documentation does not reflect current state of the art. This results in a non-conformity that you must address. - **Market surveillance actions.** Competent authorities may determine that a device no longer meets GSPR requirements because the state of the art has advanced. - **Competitive disadvantage.** Even without regulatory action, falling behind the state of the art puts you at a disadvantage in a market where buyers increasingly compare devices on safety and performance features. ## Practical Guidance for Startups ### Start with Standards For a startup, the most practical approach to state of the art is to start with harmonized standards. They represent a significant, documented, and accepted portion of the state of the art. Apply them, follow them, and you have covered a large part of the requirement. ### Supplement with Literature For areas not covered by standards — clinical state of the art, emerging technologies, novel risk control measures — use literature and expert input to document the current state of knowledge and how your design addresses it. ### Be Honest About Trade-offs Sometimes the state of the art suggests a design approach that your startup cannot afford or does not have the expertise to implement. When this happens, be transparent in your risk analysis. Acknowledge the state-of-the-art approach, explain why you chose an alternative, and demonstrate that your alternative achieves acceptable safety. This honest approach is far better than ignoring the state of the art entirely. ### Keep It Proportionate A Class I bandage does not need the same state-of-the-art analysis as a Class III implantable AI-driven therapeutic device. Proportionality applies. But even for lower-risk devices, a documented consideration of the state of the art — however brief — is better than no consideration at all. ## The Bottom Line The state of the art principle in MDR is not a vague aspiration — it is a concrete requirement that affects design, risk management, clinical evaluation, and lifecycle management. It asks a simple question: did you design and manufacture this device using the current knowledge and technology available to a competent manufacturer? For startups, the practical path is clear: apply current standards, monitor current literature, make design decisions based on current knowledge, and document your reasoning. The state of the art is not about perfection — it is about competence, diligence, and honest engagement with the current state of knowledge in your field. --- *This post is part of the [MDR Fundamentals & Regulatory Strategy](https://zechmeister-solutions.com/en/blog/category/mdr-fundamentals) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*