The Imperative for Global Coordination in Regulating AI in Medical Devices


Artificial Intelligence (AI) is a transformative technology that has permeated various sectors, including healthcare. Medical devices equipped with AI capabilities are becoming increasingly sophisticated, offering unprecedented opportunities for diagnosis, treatment, and patient care. However, the rapid advancements in AI technology also pose ethical and safety concerns that necessitate robust regulatory frameworks. This article delves into the complexities of regulating AI in medical devices, the pioneering role of the European Union’s Artificial Intelligence Act (AIA), and the urgent need for global coordination in this domain.

The Current Regulatory Landscape

United States: FDA and SaMD

In the United States, the Food and Drug Administration (FDA) regulates Software as a Medical Device (SaMD) through a risk-based approach. However, the FDA’s guidelines are often considered to be in a nascent stage when it comes to AI-specific regulations. They primarily focus on traditional software and may not fully address the unique challenges posed by AI, such as algorithmic transparency and data bias.

European Union: MDR and IVDR

In the European Union, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) have set certain standards for medical devices, including those that incorporate AI. However, these regulations are often limited to regional jurisdictions and may not comprehensively address the unique challenges posed by AI.

The EU Artificial Intelligence Act (AIA)


The European Union has taken a pioneering step with the introduction of the Artificial Intelligence Act (AIA). This act aims to lay down harmonised rules on AI and amend certain Union legislative acts. It is designed to be human-centric, focusing on safety and compliance with the law, including the respect of fundamental rights.

Focus on Medical Devices

While the AIA covers a broad spectrum of AI applications, its implications for medical devices are particularly noteworthy. The act aims to address the challenges and concerns raised by the increasing use of AI in healthcare, ensuring that AI applications considered high-risk are clearly determined and regulated.

Risk-Based Approach

The AIA adopts a risk-based approach, categorising AI systems into different levels of risk—unacceptable risk, high risk, and low or minimal risk. Medical devices with AI capabilities often fall under the high-risk category, requiring stringent compliance measures.

The Need for Global Coordination

Interoperability and Standardisation

Given the global nature of healthcare and technology, regional regulations like the AIA should serve as a blueprint for international standards. ISO standards such as ISO 13485 for medical devices can be adapted to include AI-specific guidelines, ensuring global interoperability and compliance.

Ethical Considerations

AI in medical devices raises ethical questions around data privacy, informed consent, and algorithmic bias. A globally coordinated approach can help establish universal ethical guidelines, possibly overseen by international bodies like the World Health Organization (WHO).

Safety and Efficacy

AI algorithms can evolve, making them inherently different from traditional medical devices. A coordinated global approach can ensure that safety and efficacy are maintained as the technology evolves, possibly through continuous monitoring and post-market surveillance.

The EU AIA as a Global Model

The EU AIA’s balanced, human-centric approach makes it an ideal model for global AI regulation. Its focus on both promoting AI and addressing associated risks offers a comprehensive framework that other jurisdictions can adapt and implement.

How Deviceology Can Help

For companies looking to navigate the complex landscape of global medical device regulations, Deviceology offers expert guidance and support. Whether you are aiming to comply with the EU AIA or other international standards, Deviceology can assist you in accessing global medical device markets. For more information, contact or visit


As AI continues to advance, the need for robust, globally coordinated regulation becomes increasingly urgent. The EU AIA offers a promising start, but international cooperation is essential for ensuring that AI in medical devices is safe, effective, and ethical. A globally coordinated approach, inspired by the EU AIA and supported by international standards like ISO 13485, can pave the way for a more secure and efficient healthcare ecosystem.