Artificial Intelligence (AI) is being incorporated into various medical devices, including imaging machines for faster scans and lesion detection, wearables for heart arrhythmia detection, and software systems for predicting sepsis risk in hospitals. This trend has prompted regulators to clarify their positions on AI in medical devices.
As this happens, you can expect the software engineers from India, to play an increasing role in developing, embedding and supporting the AI functions in all aspects of AI in medical devices.
The U.S. Food and Drug Administration (FDA) is working on a framework for approving changes to AI-enabled devices, while the European Union has proposed the AI Act to complement its Medical Devices Regulation. The International Medical Device Regulators Forum (IMDRF) has been a crucial platform for countries to collaborate on medical device guidance for nearly 13 years. Members include major regulatory bodies from the EU, Japan, Canada, Australia, and the U.S., with the World Health Organization as an observer. The IMDRF has developed guidance documents on various topics, from basic definitions of medical devices to regulating new technologies such as AI.
The IMDRF’s AI working group is currently focused on developing more detailed documents based on the good machine learning practices (GMLPs) established through multilateral work with the UK and Health Canada. This effort builds upon previous work on predetermined change control plans for AI-enabled devices.
Picture credit: Pixabay
Regulators worldwide face similar challenges in overseeing AI in healthcare, including:
1. Fitting AI into existing regulatory frameworks
2. Keeping up with rapidly evolving technology
3. Addressing the complexity of oversight
4. Managing the lack of manpower to handle the increasing use of AI in medical devices. This is where India will play a major role
Regulators are working to balance innovation with patient safety, striving to create flexible yet robust frameworks that can keep pace with technological advancements. The involvement of both established and emerging regulatory bodies, along with industry stakeholders, will be crucial in shaping the future of AI regulation in medical devices.
Last updated: December 26th, 2025
