Day 1 - Monday 15th JuneMonday, 15 June 2026 - CEST Time Zone

• Discussing the MDR/IVDR proposal -moving MDAI from Section A to Section B of Annex I
• Extended grace periods under the Digital Omnibus on AI - What do the new timelines mean for compliance planning?

• Exploring the importance of explainable AI in building trust among stakeholders by making AI decisions more transparent and understandable.

• Addressing the growing demand for explainability in AI to meet regulatory requirements and ensure ethical decision-making in critical applications.

• Discussing tools, techniques, and challenges in integrating explainable AI into real-world systems without compromising performance.
  
  

• Exploring how AI drift impacts the accuracy and reliability of medical devices over time and the need for proactive monitoring strategies.

• Evolving Post-Market Surveillance - addressing the role of PMS in detecting and mitigating AI drift through continuous monitoring, real-world data validation, and performance assessments.

• Defining the Gray Zone - examining the challenges of regulating AI-enabled medical devices and their convergence with non-device technologies.

• Exploring existing and emerging regulatory approaches to address the blurred lines between AIeMD and non-device solutions.

• Highlighting the impact of this convergence on manufacturers, regulators, and healthcare providers, with strategies to navigate compliance and innovation.

• An overview of the key features of new EU product liability framework, with a focus on new legal risks for software developers.
• An understanding of the growing role of product safety compliance in product liability litigation.
• An update on transposition across the EU, and how to prepare for claims alleging harm caused by SaMD and AI.

• Reviewing key insights gained from data collection requirements under the AI Act and their implications for compliance.

• Addressing practical obstacles in meeting data collection standards, including transparency, quality, and governance.

• Exploring how organizations can adapt their data strategies to align with evolving requirements and ensure long-term compliance.

For more information, please contact Neha Singh at niha.singh@informa.com

• Sharing first-hand experiences of SMEs in preparing for compliance, including resource and knowledge gaps.

• Offering actionable steps and best practices for SMEs to meet the EU AI Act deadline effectively.