AI Regulation in Focus as New White Paper Guides Medical Device Developers
A new white paper aiming to help companies safely design, launch, and maintain AI-enabled medical devices across major global markets has been published by regulatory consultancy IMed Group and Edinburgh-based life sciences software agency Firefinch Software.
Overview of the White Paper
Titled Smart Code, Safe Care: Navigating AI Acceleration in Regulated Medical Devices, this free publication is intended for organisations developing software-based or AI-powered products for the UK, US, and EU. Its authors highlight that the rapid growth of AI in healthcare is creating both opportunities and significant regulatory challenges for innovators.
Key Insights for Companies
Businesses, ranging from university spinouts to established manufacturers integrating new AI components, must address a series of technical and regulatory requirements to ensure their products can enter—and remain in—target markets.
The paper outlines how differing international frameworks can complicate compliance efforts, despite each regulator placing patient safety at the centre of their approach. As guidance evolves, companies are being required to adopt new skills and processes spanning:
- Software engineering
- Clinical risk management
- Cybersecurity
- Data science
- Regulatory governance
Ethical Considerations and Governance
Teams working with probabilistic AI systems must implement ethical data management practices, apply robust AI governance structures, navigate ISO standards, and respond to shifting regional requirements.
Classification and Regulatory Bodies
The publication provides an explanation of how digital components contribute to a medical device’s classification, alongside an overview of how regulatory bodies in the UK, US, and Europe approach Software as a Medical Device (SaMD) and AI-driven technologies. It highlights areas of alignment as well as divergence between jurisdictions.
Industry Perspectives
According to industry experts, there is growing demand for clarity in regulatory processes. One expert noted, “We’re continuing to provide our insights to the market in the form of expert commentary and guidance as we understand that lack of clarity is one of the key obstacles SaMD and AI device businesses face today.”
Furthermore, the digital medical device market is rapidly adapting, with an increase in partnerships between internal medical device developers and external teams equipped to navigate the nuanced regulatory landscape concerning the use of AI and its medical device applications. These collaborations help businesses avoid costly rework while maintaining patient safety and privacy.
Accessing the White Paper
To access the white paper, visit the link provided below:
