EU AI Act Compliance for Medical Devices

Regulation (EU) 2024/1689 (EU AI Act) establishes the world's first comprehensive legal framework for artificial intelligence systems developed, deployed or placed on the EU market. The Regulation introduces a risk-based approach to AI governance, classifying systems into prohibited, high-risk, limited-risk and minimal-risk categories, each with distinct obligations for providers, deployers, importers and distributors. It was adopted to ensure that AI systems placed on the EU market are safe, transparent and respect fundamental rights, while fostering innovation and maintaining the EU's competitiveness in AI development.

This training session provides participants with a practical understanding of the EU AI Act's requirements, its application timelines, and the obligations it introduces across the AI value chain. Participants will learn how to assess their AI systems against the regulatory framework, understand their role-specific responsibilities and develop strategies to achieve and maintain compliance ahead of the applicable deadlines.

Key Topics Covered:

• Overview of Regulation (EU) 2024/1689 and its risk-based regulatory structure
• Scope, key definitions and role allocation under the EU AI Act
• Classification of high-risk AI systems under Article 6, Annex I and Annex III
• Obligations for providers and deployers of high-risk AI systems
• Technical documentation, quality management, transparency, logging, human oversight, post-market monitoring and corrective actions
• Roles and responsibilities across the AI value chain: providers, deployers, importers, distributors, authorized representatives and product manufacturers
• EU AI Act application timelines and transitional provisions
• Interaction between the EU AI Act and MDR for AI-enabled medical devices
• Practical mapping of AI Act requirements into MDR technical documentation and QMS processes
• Q&A sessions and practical discussion

Benefits

• Gain a clear and practical understanding of the EU AI Act and its regulatory intent
• Identify whether AI systems fall within prohibited, high-risk, or lower-risk categories
• Understand which obligations apply depending on the organization’s role in the AI value chain
• Learn how high-risk AI system requirements relate to technical documentation, conformity assessment, quality management, and post-market monitoring
• Understand how AI Act requirements can be merged with MDR expectations for AI-enabled medical devices and medical device software
• Prepare your organization for upcoming application deadlines and reduce the risk of compliance gaps

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Target Audience: Regulatory, Quality, Risk Management and Compliance professionals for AI-enabled medical devices, regulatory Affairs specialists, quality managers, auditors, consultants, and technical documentation experts, Professionals implementing EU AI Act requirements within MDR and QMS processes, software engineers, AI specialists, data scientists, cybersecurity and product teams, manufacturers, providers, importers, distributors and other economic operators in the AI medical device value chain. Basic knowledge of medical device regulation, QMS or AI-enabled products is beneficial.