State of the Art in Clinical Evaluation: A Strategic Approach to MDR Compliance
Introduction
The term “State of the Art,” often abbreviated as SOTA or SoA, has gained significant traction in the realm of clinical evaluation, especially with the updates in the EU Medical Device Regulation 2017/745 (MDR) and MEDDEV guidelines. This article aims to provide a comprehensive understanding of what “State of the Art” means in practice and how to leverage it effectively for CE marking your medical device.
Unpacking the Definition of "State of the Art"
The term has seen a surge in mentions, from just three times in the 93/42/EEC amended by Council Directive 2007/47/EC (MDD) to 12 times in the MDR. The IMDRF/GRRP WG/N47 FINAL:2018 and MDCG 2020-6 have provided some clarity, defining it as a “developed stage of current technical capability and/or accepted clinical practice.” Despite this, the term remains open to interpretation, making it essential to understand its practical implications in clinical evaluation and device development.
Leveraging "State of the Art" in Device Development
Understanding “State of the Art” is not merely an academic exercise; it has real-world implications for device development. This includes understanding current medical practices, knowing your competitors, and being aware of all available literature data for equivalent or similar devices.
Risk Management and Device Claims
An early understanding of the state of the art can significantly influence your risk management strategies and device claims. It helps set the acceptance criteria for performance and safety, ensuring your device is competitive in the market.
Clinical Outcome Parameters and Data Collection
The state of the art also informs the selection of endpoints (clinical outcome parameters) and shapes your data collection plan. This is vital for both pre-market and post-market phases, aiding in the design of a robust clinical evaluation strategy.
Clinical Evaluation Strategy
Being aware of the state of the art can guide you in choosing the most appropriate clinical evaluation strategy. Whether it’s relying on data from an equivalent device, considering your device as a well-established technology, or generating sufficient clinical data for MDR compliance, a well-designed state of the art analysis can provide valuable insights.
The Dynamic Nature of "State of the Art"
It’s important to note that the state of the art is not static; it evolves with advancements in medical practice and technology. Therefore, it’s advisable to update your understanding, especially during the completion of the Clinical Evaluation Report (CER).
Summary and Conclusion
The analysis of the state of the art is a mandatory requirement under MDR and should ideally be conducted early in the device development process. It provides invaluable data that can guide risk management, device claims, endpoints, and clinical evaluation strategy. Given its dynamic nature, an update is generally expected towards the end of the project, particularly during the CER completion
By understanding and effectively leveraging the “State of the Art” in the context of MDR and clinical evaluation, manufacturers can not only ensure compliance but also gain a competitive edge in the ever-evolving medical device market.
