Much of the classification guidance for software has to do with its intended purpose. This area of regulation desperately needed more in-depth directives. The sheer amount of new intended purposes has far exceeded the volume of regulatory updates from the EU. Not only have intended purposes expanded greatly, but also the ability to assist in the decision-making process mandates further directives from regulatory authorities in this space. For example, software that supplies information to assist in making decisions regarding diagnostic or therapeutic purposes will now be Class IIa. There is one important exception to this rule though, i.e..if the pending decision has the potential to cause death or an extreme irreversible health issue of the patient will be classified as Class III.
Another area that saw proportional expansions to their regulations, is the elevated risk of the software due to rise in software capabilities and functionality. To this point, Class IIb will include devices that could cause serious deterioration of the patient’s health but are not irreversible. Devices that simply monitor the anatomical processes of a patient will be Class IIa but will be classified as IIb if the process being monitored could result in immediate danger to the patient of the measurements stray too far.
One last area of interest for the industry is SaMD devices that involve a transfer of energy between the device and the patient. These types of devices have developed extremely quickly, but even so, their complete medicinal potential has certainly not been realized. As such, Rule 9 of the regulation governs devices that are intended to exchange or administer energy, which will be Class IIa. Further, these devices will be classified as IIb if the process by which the energy is transferred is potentially hazardous. Additionally, Rule 10 of the same Annex states that devices that are intended to “monitor and diagnose” will be class IIa if energy is absorbed by the body from the device. Devices such as these would be upgraded to class IIb if the device monitors a parameter that could be potentially life threatening (central nervous system, respiratory issues, and cardiac activity).
For complete guidance on SAMD, explore here.
While the feedback loop for SaMDs drives innovation and faster product iteration, the industry also faces a fundamental challenge on examining how to develop a product for a fast-changing, ever-evolving “internet of everything” world while demonstrating continued patient safety, clinical efficacy, and adhering to regulatory compliance?
One of the best ways for companies to address this includes continued notified body and IRB involvement for high-risk devices while enabling a faster feedback loop including, risk-based software segregation, development of the software involving formative human factors coupled with real-world performance analytics, and an effective clinical validation and quality management system.
Software as medical device products seem to have exponential growth in terms of connectivity and capabilities. As one development can lead to three of four more device advancements, and so on, and so forth. Thus, it is no secret that regulatory bodies are planning on enacting regulatory frameworks that allow for clear and straightforward guidance in the coming years as new and more advanced devices come to the market.
From everything I’ve heard from individuals at cutting edge, and major device manufacturers, is that the key trend is connectivity, and their diagnostic implications. Additionally, a major driver in SaMD development is the rise of smartwatches. Not only are they generally affordable, they offer a convenient, and even stylish tool to monitor a variety of health metrics. While medical uses were not likely to have been the impetus for smartwatch developments, they have effectively altered medical device capabilities forever.