While obtaining a CE/UKCA mark is an essential step in the regulatory process for Software as a medical device (SaMD) in Europe/UK, it is important to recognise that additional clinical studies are often required to comprehensively evaluate these products. This article sheds light on what CE/UKCA marking signifies for SaMD, as well as its limitations.
What is CE/UKCA marking?
The CE/UKCA mark demonstrates that a product has undergone conformity assessment procedures, ensuring compliance with relevant EU/UK directives or regulations including safety and performance requirements. The medical device regulation was originally designed for hardware medical devices but is also now used for software medical devices (SaMD) including AI medical devices (AIaMD).
SaMD are subject to specific regulations depending on their risk classification and intended use. For lower risk Class I devices it involves self-assessment whilst for Class IIa/b and Class III devices it involves engaging a notified body to perform a conformity assessment review, which includes an audit of the technical documentation, quality management system, and clinical evaluation documentation.
While CE/UKCA marking represents an important step towards assessing conformity of SaMD it is essential to recognise its limitations, particularly in the field of novel digital technologies.
Clinical Validation
To obtain a CE/UKCA mark, SaMD products must undergo a clinical evaluation. However, the scope of the clinical evaluation required may be limited and focused primarily on safety and performance, rather than comprehensive clinical validation. This restricted assessment may not provide sufficient evidence to fully evaluate the clinical utility and effectiveness of the SaMD product in real-world scenarios.
In an analogy to medication, CE/UKCA marking for SaMD can be compared to the initial clinical trials that evaluate the safety and efficacy of a new drug. Just as these trials provide valuable information about the drug's performance in controlled settings, CE/UKCA marking offers a framework to assess the conformity and regulatory compliance of Software as a Medical Device (SaMD) within established standards.
A CE/UKCA mark does not inform you how a product compares to others in terms of performance or which product is the best to use in a given clinical scenario.
Therefore, additional clinical assessment is likely to be required to inform commissioning decisions for SaMD.
Additional evidence standards frameworks such as the NICE evidence standards framework for Digital Health Technologies have been developed in an attempt to ensure that SaMD are clinically effective and to assist evaluators and decision makers to identify products that are likely to offer benefits to users and the health and care system.
Evolving Technology and Rapid Innovation
It can be challenging for regulation to keep pace with the rapid technological advancements of SaMD.
Emerging technologies such as artificial intelligence, machine learning, and blockchain introduce complexities such as ‘black box’ algorithms and rapid iteration of software necessitating tailored regulatory approaches.
Several regulatory changes are on the horizon to attempt to overcome the current limitations. These include predetermined change control plans, the UK software and AI as a medical device change programme, the EU AI act and the US Algorithmic accountability act.
Post-Market Surveillance and Feedback
Post-market surveillance (PMS) is a crucial aspect of medical device regulation that involves ongoing monitoring of products after they have been placed on the market. It allows for the detection of potential safety issues, assessment of real-world performance, and collection of user feedback.
While PMS activities are essential for all medical devices, SaMD products often benefit from continuous data collection, analysis, and iterative improvements.
Additional clinical studies can aid in validating the safety and efficacy of SaMD products based on real-world data and user feedback gathered during PMS.
Conclusion
While obtaining a CE/UKCA mark is an important milestone for SaMD products, it should be viewed as a starting point rather than the final destination for product evaluation. The limited scope of clinical evaluation during the CE/UKCA certification process necessitates additional clinical studies to comprehensively assess the real-world performance of SaMD. The dynamic nature of the technological landscape, varied clinical contexts, post-market surveillance, and the need for comparative effectiveness evidence further underscore the importance of additional clinical studies for SaMD products.
Through a rigorous and iterative approach to clinical evaluation, we can ensure that SaMD products meet the highest standards of safety, efficacy, and patient care in an evolving healthcare landscape.
