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Medical Devices

Innovating Regulation: The Use of AI by Notified Bodies for Conformity Assessment

Wednesday, May 14, 2025
08:30 - 09:30 CEST
Location: Silver Hall (level 0)
Description: Participants attending the session "Innovating Regulation: The Use of AI by Notified Bodies for Conformity Assessment" will benefit from exploring how AI is currently being utilized—and the reality of its limited adoption—in the regulatory industry. While AI has been widely discussed as a potential game-changer, its actual use in regulatory practice remains in its early stages, often surrounded by skepticism, limited resources, and a lack of clear guidelines or best practice.

This session will present the findings of researcher Ingela Mauritzon's study, offering a unique understanding of how AI is practically applied by regulatory bodies. Attendees will gain insights into the hurdles that exist in adopting AI, such as regulatory compliance challenges, data integrity concerns, and the resistance to change within regulatory organizations. The discussion will also cover how these barriers can be addressed to unlock AI's potential to streamline processes, improve accuracy, and enhance decision-making.

By attending, participants will deepen their understanding of the practical realities and future possibilities of AI in regulatory work, equipping them with a realistic perspective on navigating the evolving regulatory landscape.

Learning Objectives:

  • Understand the Current State of AI Adoption in Regulatory Work: Participants will gain a clear understanding of how AI is being used by Notified Bodies for conformity assessment, including the extent of its adoption, common use cases, and the practical challenges faced by regulatory professionals in integrating AI tools into their workflows.
  • Identify Barriers to AI Implementation in Regulatory Contexts: Attendees will learn about the key obstacles hindering the widespread adoption of AI in the regulatory industry, such as issues related to data quality, compliance, transparency, and organizational resistance. This will help participants recognize potential pitfalls and develop strategies to overcome these challenges in their own organizations.
  • Explore Future Opportunities for AI in Enhancing Regulatory Practices: Participants will explore potential areas where AI could bring significant improvements in regulatory work, such as streamlining documentation, enhancing risk assessments, and improving overall decision-making. The session will provide actionable insights on how to approach AI adoption thoughtfully and strategically to maximize benefits while mitigating risks.