20 October 2025

The Global Medical Device Nomenclature (GMDN) Agency today announced the results of a recent survey conducted among national medical device regulators, revealing that an overwhelming 93% believe the next significant crisis in medical devices will centre on software, Artificial Intelligence (AI), or Machine Learning (ML) technologies.

As medical devices become increasingly reliant on advanced algorithms and digital platforms, regulators are anticipating a shift in potential safety risks and crisis management. Notably, 86% of those surveyed believe that the next medical device crisis will occur within the next five years, highlighting the urgency of addressing these emerging risks.

The survey, conducted last month (September 2025), asked regulatory bodies from across the globe to identify areas of greatest concern for the next wave of medical device incidents. An almost unanimous response pointed to the rapid integration of software, AI, and ML as the most likely source for future challenges.

Graham Nash, Health Data Strategy Lead at the GMDN Agency, commented: “The acceleration of digital technologies in healthcare is transforming the way we deliver patient care, but it also means we must adapt our approach to regulation and data management. Collaboration and shared insight are essential for identifying and mitigating risks before they escalate into wider issues.”

“This result highlights an important trend in healthcare,” said Deniz Bruce, CEO of the GMDN Agency. “As more medical devices incorporate digital technologies, new types of risks are emerging. The GMDN’s global classification system is designed to help regulators and manufacturers improve post-market surveillance by providing a shared language and dependable data tools. Our aim is to support the safe use of new technologies and help ensure that innovation continues to benefit patients everywhere.”

The GMDN Agency continues to play a pivotal role in global harmonisation, enabling efficient communication among regulators, manufacturers, and healthcare providers. By leveraging the power of the GMDN system in post-market surveillance, the industry can rapidly identify patterns, monitor device performance, and intervene early to prevent widespread incidents—especially as software and AI become critical elements of patient care.