Preparing for the EU Artificial Intelligence (AI) Act: Key Considerations for the Medical Device Industry
The EU AI Act came into force on 1 August 2024 and is set to reshape the MedTech sector, significantly impacting the use of medical devices in Scotland and beyond. This legislation presents a fundamental shift in how medical technologies will be regulated and monitored, with implications not just for European businesses but for any organization marketing or using AI-based medical devices in the EU.
Why Compliance Matters
With almost two-thirds of UK healthcare organizations already leveraging AI in their operations, the EU AI Act represents a crucial framework for ensuring safety, efficacy, and compliance in AI applications. If a medical device utilizes AI and is used or marketed in the EU, it must adhere to the Act’s requirements, regardless of the company’s location.
As the EU AI Act becomes enforceable by 2026, organizations must begin their preparations now, particularly those dealing with EU partners or customers. Compliance is essential not only to avoid penalties but also to build trust and enhance the quality of healthcare services.
Understanding High-Risk Systems
Healthcare organizations need to pay special attention to high-risk systems. Medical devices that incorporate AI or operate as independent AI systems will be categorized as high-risk due to their potential impact on patient health and safety. This classification triggers a series of stringent technical compliance measures that must be met.
Technical Compliance Requirements
To aid businesses in navigating the classification of high-risk AI systems, the following technical compliance requirements must be adopted:
- Comprehensive Risk Management Systems: AI systems in medical devices must have a robust, ongoing risk management process that includes monitoring throughout the product’s lifecycle, not just during design and development phases.
- Regulatory Quality Standards: High-quality, compliant data sets are critical for the safety and performance of AI-driven medical devices. Poor data quality can compromise diagnostic or therapeutic decisions, endangering patients and risking non-compliance with the EU AI Act.
- Technical Documentation: Companies must produce technical documentation to demonstrate compliance and ensure human oversight. This is crucial for high-risk AI systems that may make diagnostic or therapeutic decisions.
- Accuracy, Robustness, and Cybersecurity: AI-powered devices must be designed with cybersecurity safeguards, as outlined by the Act. Companies should provide deployers with comprehensive instructions for use (IFUs) to ensure the safe use of medical devices.
Consequences of Non-Compliance
Penalties for non-compliance can be severe, including fines of up to 6% of global annual turnover. Inadequate data management, poor oversight, and weak risk management frameworks could lead to companies being pushed out of the market. Therefore, immediate preparation is essential.
Embracing the Opportunity
As AI innovation accelerates, regulators are striving to keep pace. While compliance with the EU AI Act may present challenges, it also offers an opportunity for organizations to enhance their systems and build trust in their products. Scottish healthcare organizations and the broader MedTech sector must proactively adapt to these regulations to thrive in a rapidly changing landscape.
