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Online seminar: The New EU AI Act (Regulation (EU) 2024/1689): Impact on Medical Devices and Healthcare Institutions

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The new AI Act – Regulation (EU) 2024/1689 is the European Union’s first comprehensive legislation on artificial intelligence (AI). It introduces a unified framework that significantly affects the development and use of AI-powered systems across industries, including medical devices.
As AI capabilities become increasingly integrated into medical technologies, this regulation is not only relevant to manufacturers but also to healthcare providers, who use AI in diagnostics, treatment, and operational management. The AI Act enforces stringent requirements on safety, transparency, and accountability, demanding major adjustments in compliance processes and technical documentation.

What You Will Learn

Gain a clear understanding of the AI Act and how it intersects with the Medical Device Regulation (MDR - Regulation (EU) 2017/745). Learn how to successfully integrate both sets of requirements into your development and business processes.

The seminar will cover:

  • Key concepts and objectives of the AI Act
  • AI system classification based on risk levels
  • The relationship between the AI Act and MDR: shared and specific requirements
  • New obligations for technical documentation, quality management systems, and conformity assessment procedures
  • The course provides practical insights into the legal requirements and their real-world impact on high-risk AI systems in the healthcare and medical device sector.

Format and Participation

  • Live e-seminar in a virtual classroom.
  • Access link will be provided two days before the event.
  • You will need a computer with microphone, camera, and a reliable internet connection.

Who Should Attend

This training is designed for:

  • Medical device software manufacturers
  • Regulatory affairs and quality assurance professionals
  • Compliance officers and legal experts
  • Healthcare providers and clinical users of AI technologies

Additional information: Bojan Varga, phone: +386 01 4778 108, e-mail: bojan.varga@siq.si

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