AI impact on medical devices

AI is revolutionizing the Life Sciences sector by offering technological solutions that can significantly affect new product development, patient care, and the efficiency and sustainability of national healthcare systems.

The qualification of AI-based software as medical devices

From a regulatory standpoint, products containing AI-based software can be classified as medical devices depending on the specific intended use identified by the manufacturer. Generally, only software with a medical purpose — such as diagnosis, monitoring, or disease prevention — qualifies as a medical device. Conversely, software with a “generic” and non-medical diagnostic intended use does not fall under this category, even if intended for use in a healthcare context.

For instance, software that collects, archives, stores, or transmits data acquired through specific electromedical equipment creates a database that can be accessed when providing healthcare services.

However, since it lacks a specific medical purpose, it typically does not qualify as a medical device. The classification of software as a medical device is essential as it entails applying specific requirements to ensure the health and safety of patients and users.

Undoubtedly, the medical device sector has witnessed a substantial increase in the use of AI software in recent years. These systems and solutions improve diagnostic accuracy, reduce human error by identifying pathologies more precisely, and provide therapeutic options that enhance the chances of recovery, positively affecting treatment effectiveness. The improved efficiency of available tools leads to shorter access times and treatment durations, benefiting patients and healthcare systems.

Examples of medical devices using AI

Numerous examples of medical devices use AI, ranging from software that helps doctors in disease diagnosis to those suggesting personalized treatment options based on specific patient data, such as genetic profiles.

AI has also found applications in radiology, where various software currently available on the market analyze image data and detect anomalies. Additionally, AI increasingly helps surgeons in performing delicate operations through sophisticated devices.

However, medical devices using AI need not necessarily be complex products accessible only to healthcare professionals. On the contrary, several solutions have been specifically designed to be available to patients for the daily management and monitoring of various conditions. A notable example includes products for patients with diabetes that continuously monitor blood sugar levels and automatically adjust insulin administration.

The impact of the AI Act on medical devices

While AI software for medical purposes is currently considered a medical device from a regulatory perspective, it’s essential to consider a potential regulatory innovation that could affect the entire sector. The EU is discussing the proposed AI Act, which may significantly affect medical devices incorporating AI software. According to the provisions outlined in the proposal, these products could be subject to a dual regulatory regime encompassing both medical devices and AI-containing products, resulting in increased regulatory obligations for all stakeholders in the supply chain.