For medical device manufacturers aiming to comply with the European Union Medical Device Regulation (EU MDR 2017/745), a robust “State-of-the-art” (SOTA) section is crucial for demonstrating clinical safety and performance.
What is the SOTA section?
The SOTA section defines the current benchmark of medical and technological advancements related to your device. This section does not simply summarise existing knowledge but provides a framework for comparing your device to current standards and competing alternatives.
Why is the SOTA section important?
In the EU MDR framework, the SOTA section substantiates your device’s position relative to similar products, highlighting both safety and effectiveness. Not only does it showcase the clinical benefits of your device, but it also establishes a foundation for identifying any risks and performance gaps, particularly when weighed against similar devices.
What should I include within the SOTA section?
1. Clinical background
– A description of the medical fields concerned and associated medical conditions
– Historical context and developments
– Epidemology
– Types of users or patient population affected
2. Current knowledge
– A description of available therapeutic/management/diagnostic options- thier advantages and disadvantages
– Description of the benefits and risk, acceptability of undesirable side-effects
– Discuss any applicable standards and guidance documents
– Highlight any unmet medical needs
– Medical alternatives available, including evidence of clinical performance and safety
– Justify the validity of criteria used for the demonstration of equivalence (if equivalence is claimed)
3. Context of the DUE in terms of the SOTA
– Describe the position of the device under evaluation (DUE) within the treatment portfolio – Deficiencies in current therapies should be identified
– Provide a summary comparing the DUE with other devices that are similar in terms of clinical, biological and technical characteristics.
– Data on the safety and performance of other devices and alternative therapies, including benchmark devices, competitor devices and equivalent devices, which should be used to define the state of the art.
Can I put historical ‘equivalency’ data in the SOTA?
YES – Manufacturers of legacy devices previously certified under EU MDD may have previously taken the equivalency route for their clinical evaluation. Whilst equivalency may not be an option under EU MDR, all the information previously gathered can be used to support the state-of-the-art, relevant to similar devices.
How can Advena UK help?
1. Expert Guidance and Strategic Planning – help you create comprehensive SOTA section and conduct extensive literature searches. Advena can provide an unbiased approach to compare your device with its peers.
2. Comprehensive Comparative Analysis – a thorough analysis of clinical safety and performance data between benchmark devices and your device/s. Ensuring all relevant information is captured.
3. Robust Documentation Preparation – help prepare comprehensive and well-structured clinical evaluation report/s. Collect and present robust clinical data from the similar device, supplemented with any available data for your device, providing scientific justifications for safety and performance claims, including thorough risk analysis and mitigation strategies.
In addition, we can also provide:
- Full technical documentation review/creation
- Assistance with regulatory submissions and interactions with regulatory authorities
- Training/knowledge transfer
- ISO13485 Quality Management System creation, management and support
Contact Us
For further information and personalised guidance on completing the SOTA section of your clinical evaluation reports, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153).
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