AI and the EU AI Act for Medical Devices

The Artificial Intelligence Act establishes a regulatory and legal framework for AI within the EU. It covers most AI systems, with exemptions for AI used only for military, national security, research purposes, or for non-professional use. The Act classifies AI applications by their risk of causing harm.

There are four levels - unacceptable, high, limited, minimal - plus an additional category for general-purpose AI. Applications with unacceptable risks are banned. High-risk applications must comply with security, transparency and quality obligations, and undergo conformity assessments by a Notified Body. Limited-risk applications only have transparency obligations. Minimal-risk applications are not regulated. For general-purpose AI, transparency requirements are imposed, with reduced requirements for open source models, and additional evaluations for high-capability, higher risk models. They must be evaluated both before they are placed on the market and throughout their life cycle. The list of high-risk applications can be expanded over time without modifying the AI Act itself.The risk-based scheme asssigns regulatory duties to providers and deployers of AI systems. These duties become more demanding as the impact on health, safety, or fundamental rights increases.

This ensures that the focus is on systems with significant risks while allowing lighter approaches for lower risks. For providers of general-purpose AI models: They must publish a summary of the training data, adopt a policy to comply with copyright law, and provide technical documentation to downstream providers and supervisory authorities. Models designated as posing systemic risk must also carry out model evaluations and adversarial testing, assess and mitigate risks such as bias and security failures, report serious incidents, and ensure an adequate level of cybersecurity.

Why you should Attend:
This webinar will cover the EU'S approach to unified AI governance throughout the member states of the EU for all AI enabled products and systems. This webinar will focus on the medical device segmanet of those products and systems and manufacturer's roles and responsebilities in the adherence to them. These requirements apply to all manufacturere marketing and selling into the EU market, regarless of where the devices are actually manufactured. AI is a fast evolving family of technologies that contributes to a wide array of economic, environmental and societal benefits across the entire spectrum of industries and social activities.

By improving prediction, optimising operations and resource allocation, and personalising digital solutions available for individuals and organisations, the use of AI can provide key competitive advantages to undertakings and support socially and environmentally beneficial outcomes, e.g., in healthcare. On the other hand, AI may generate risks and cause harm to public interests and fundamental rights that are protected by Union law. Such harm might be material or immaterial, including physical, psychological, societal or economic harm. These new requirements are designed to address both. The ultimate goal: AI should be a human-centric technology. It should serve as a tool for people, with the ultimate aim of increasing human well-being.

Areas Covered in Session:

• The EU AI Act of 2024, with focus on Medical Devices
• A Risk-Based Approach
• Key Points
• Enforcement
• The Notified Body's Role
• Basic Documentation Requirements

• Senior management in Devices, AI Technology
• Marketing
• QA
• RA
• R&D
• Engineering
• Production
• Operations
• Consultants; others tasked with AI product projects